The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart team.
This study is a prospective, multi-center, single-arm clinical evaluation of the AVJ-514 System for the treatment of symptomatic chronic severe mitral regurgitation (MR) in Japanese subjects deemed difficult for mitral valve surgery by the local site heart team. Patients will be evaluated at baseline, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years in Japanese Medical Centers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients receiving AVJ-514 device
Shonan Kamakura General Hospital
Kanagawa, Japan
Sendai Kosei Hospital
Miyagi, Japan
National Cerebral and Cardiovascular Center
Osaka, Japan
Keio University Hospital
Tokyo, Japan
Number of Participants With Acute Procedure Success (APS)
APS is defined as successful implantation of the AVJ-514 device(s) with resulting MR severity of 2+ or less as determined by the Echocardiographic Core Laboratory (ECL) assessment of a discharge echocardiogram. Subjects who die or who undergo mitral valve surgery before discharge are an APS failure.
Time frame: On day 0 (the day of procedure)
Percentage of Participants With Major Adverse Events (MAE) at 30 Days
MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).
Time frame: 30 days
Percentage of Participants With MAE at 1 Year
MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).
Time frame: 1 year
Number of Participants With MAE Occurring After the Femoral Vein Puncture for Transseptal Access
MAE listed below will be adjudicated by the Clinical Events Committee at 30 days: * Death * Stroke * Myocardial infarction * Renal failure * Non-elective cardiovascular surgery for device or procedure related adverse events
Time frame: 30 days
Number of Participants With Mitral Valve Stenosis Requiring Surgery
Defined as a mitral valve orifice of less than 1.5 cm\^2 as measured by the Echocardiography Core Laboratory.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sakakibara Heart Institute
Tokyo, Japan
Tokyo Women's Medical University Hospital
Tokyo, Japan
Time frame: 1 year
Number of Participants With Mitral Valve Stenosis Not Requiring Surgery
Defined as a mitral valve orifice of less than 1.5 cm\^2 as measured by the Echocardiography Core Laboratory.
Time frame: 1 year
Number of Participants With Single Leaflet Device Attachment (SLDA) Requiring Surgery
SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.
Time frame: 1 year
Number of Participants With Single Leaflet Device Attachment (SLDA) Not Requiring Surgery
SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.
Time frame: 1 year
Number of Participants With Iatrogenic Atrial Septal Defect
Defined as defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention.
Time frame: 30 days
Percentage of Participants With Device Implant Rate
Defined as the rate of successful delivery and deployment of one or more AVJ-514 device with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter.
Time frame: On the day of procedure
Device Procedure Time
Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed.
Time frame: On the day of procedure
Total Procedure Time
Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE.
Time frame: On the day of procedure
Device Time
Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the AVJ-514 Delivery System (CDS) is retracted into the Steerable Guide Catheter.
Time frame: On the day of procedure
Fluoroscopy Duration
Defined as the duration of exposure to fluoroscopy during the AVJ-514 procedure.
Time frame: On the day of procedure
Length of Stay in Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-Anesthesia Care Unit (PACU) (ICU/CCU/PACU)
Length of stay in ICU/CCU/PACU is cumulative hours of Hospital stay in (PACU/CCU/ICU)
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Length of Hospital Stay Excluding Rehabilitation Stay
Length of hospital stay excluding rehabilitation stay = Length of hospital stay (Date of Discharge - Date of Admission)
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Length of Rehabilitation Stay
Cumulative days of rehabilitation stay during hospitalization.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Percentage of Participants With Discharge Status
Location to which subject was discharged (home or another facility).
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Length of Stay (Not at Baseline Facility)
If subject discharged to another facility (different from baseline facility), length of stay at facility to which subject was discharged. Length of Stay (not at baseline facility) = Sum for all eligible log lines which had been entered in Electronic Data Capture (EDC) for ICU/CCU/PACU and rehabilitation.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Number of Participants With Mitral Regurgitation (MR) Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Number of Participants With MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Number of Participants With MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time frame: 30 days
Number of Participants With MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time frame: 6 months
Number of Participants With MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time frame: 1 year
MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time frame: 24 months
MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time frame: 3 years
MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time frame: 4 years
MR Severity Grade
Time frame: 5 years
Regurgitant Volume (RV)
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Regurgitant Volume (RV)
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Regurgitant Volume (RV)
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time frame: 30 days
Regurgitant Volume (RV)
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time frame: 6 months
Regurgitant Volume (RV)
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time frame: 1 year
Regurgitant Volume (RV)
Regurgitant volume as determined by the site. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time frame: 24 months
Regurgitant Volume (RV)
Regurgitant volume as determined by the site. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time frame: 3 years
Regurgitant Volume (RV)
Regurgitant volume as determined by the site. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time frame: 4 years
Regurgitant Volume (RV)
Time frame: 5 years
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time frame: 30 days
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time frame: 6 months
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time frame: 1 year
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time frame: 30 days
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time frame: 6 months
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time frame: 1 year
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time frame: 24 months
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time frame: 3 years
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time frame: 4 years
Left Ventricular End Diastolic Volume (LVEDV)
Time frame: 5 years
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time frame: 30 days
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time frame: 6 months
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time frame: 1 year
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the site. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time frame: 24 months
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the site. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time frame: 3 years
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the site. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time frame: 4 years
Left Ventricular End Systolic Volume (LVESV)
Time frame: 5 years
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Time frame: 30 days
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Time frame: 6 months
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Time frame: 1 year
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site.
Time frame: 24 months
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site.
Time frame: 3 years
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site
Time frame: 4 years
Left Ventricular End Diastolic Dimension (LVEDD)
Time frame: 5 years
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Time frame: 30 days
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Time frame: 6 months
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Time frame: 1 year
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the site.
Time frame: 24 months
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the site.
Time frame: 3 years
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the site.
Time frame: 4 years
Left Ventricular End Systolic Dimension (LVESD)
Time frame: 5 years
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Time frame: 30 days
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Time frame: 6 months
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Time frame: 1 year
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the site.
Time frame: 24 months
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the site.
Time frame: 3 years
Left Ventricular Ejection Fraction (LVEF)
Time frame: 4 years
Left Ventricular Ejection Fraction (LVEF)
Time frame: 5 years
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time frame: 30 days
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time frame: 6 months
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time frame: 1 year
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time frame: 24 months
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time frame: 3 years
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time frame: 4 years
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time frame: 5 years
Mitral Valve Area (MVA)
It is the orifice area of the mitral valve.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Mitral Valve Area (MVA)
It is the orifice area of the mitral valve.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Mitral Valve Area (MVA)
It is the orifice area of the mitral valve.
Time frame: 30 days
Mitral Valve Area(MVA)
It is the orifice area of the mitral valve.
Time frame: 6 months
Mitral Valve Area(MVA)
It is the orifice area of the mitral valve.
Time frame: 1 year
Mitral Valve Area (MVA)
It is the orifice area of the Mitral Valve
Time frame: 24 months
Mitral Valve Area (MVA)
It is the orifice area of the Mitral Valve.
Time frame: 3 years
Mitral Valve Area (MVA)
It is the orifice area of the Mitral Valve.
Time frame: 4 years
Mitral Valve Area (MVA)
Time frame: 5 years
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Time frame: 30 days
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Time frame: 6 months
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Time frame: 1 year
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.
Time frame: 24 months
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.
Time frame: 3 years
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.
Time frame: 4 years
Mean Mitral Valve Pressure Gradient (MVG)
Time frame: 5 years
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Time frame: 30 days
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Time frame: 6 months
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Time frame: 1 year
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.
Time frame: 24 months
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.
Time frame: 3 years
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.
Time frame: 4 years
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time frame: 5 years
Forward Stroke Volume (FSV)
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Forward Stroke Volume (FSV)
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Forward Stroke Volume (FSV)
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Time frame: 30 days
Forward Stroke Volume (FSV)
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Time frame: 6 months
Forward Stroke Volume (FSV)
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Time frame: 1 year
Forward Stroke Volume (FSV)
Time frame: 24 months
Forward Stroke Volume (FSV)
Time frame: 3 years
Forward Stroke Volume (FSV)
Time frame: 4 years
Forward Stroke Volume (FSV)
Time frame: 5 years
Cardiac Output (CO)
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Cardiac Output (CO)
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Cardiac Output (CO)
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Time frame: 30 days
Cardiac Output (CO)
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Time frame: 6 months
Cardiac Output (CO)
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Time frame: 1 year
Cardiac Output (CO)
Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.
Time frame: 24 months
Cardiac Output (CO)
Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.
Time frame: 3 years
Cardiac Output (CO)
Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.
Time frame: 4 years
Cardiac Output (CO)
Time frame: 5 years
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Time frame: 30 days
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Time frame: 6 months
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Time frame: 1 year
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.
Time frame: 24 months
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.
Time frame: 3 years
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.
Time frame: 4 years
Cardiac Index (CI)
Time frame: 5 years
Number of Participants With All-cause Mortality
Time frame: 1 year
All-cause Mortality
Time frame: 24 months
All-cause Mortality
Time frame: 3 years
All-cause Mortality
Time frame: 4 years
All-cause Mortality
Time frame: 5 years
Number of Participants With the Primary Safety Composite of MAE at 1 Year
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. No of Participants with the MAEs at 12 months. One death and One Renal Failure was reported in two subjects.
Time frame: 12 months
Freedom From the Components of the Primary Safety Composite of MAE
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Time frame: 24 months
Freedom From the Components of the Primary Safety Composite of MAE
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Time frame: 3 years
Freedom From the Components of the Primary Safety Composite of MAE
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Time frame: 4 years
Freedom From the Components of the Primary Safety Composite of MAE
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Time frame: 5 years
Number of Patients With New York Heart Association (NYHA) Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Number of Participants With NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 30 days
Number of Participants With NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 6 months
Number of Participants With NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 1 year
NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 24 months
NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 3 years
NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 4 years
NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 5 years
Kansas City Cardiomyopathy Questionnaire Quality of Life (KCCQ QoL) Scores
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
KCCQ QoL Scores
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time frame: 30 days
KCCQ QoL Scores
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time frame: 6 months
KCCQ QoL Scores
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time frame: 1 year
Change in KCCQ QoL Scores From Baseline to 1 Year
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time frame: Baseline to 1 Year
KCCQ QoL Scores
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time frame: 24 months
KCCQ QoL Scores
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
Time frame: 3 years
KCCQ QoL Scores
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
Time frame: 4 years
KCCQ QoL Scores
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
Time frame: 5 years
SF-36 QoL Scores
The Short Form(SF) (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The physical \& mental functions were assessed by the Physical Component Summary (PCS) score \& Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS\&MCS norms for 65-75 year old are 44 \& 52, respectively while the norms for congestive heart failure (CHF) population are 31 \& 46, respectively.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
SF-36 QoL Scores
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The physical \& mental functions were assessed by the Physical Component Summary (PCS) score \& Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS\&MCS norms for 65-75 year old are 44 \& 52, respectively while the norms for CHF population are 31 \& 46, respectively.
Time frame: 30 days
SF-36 QoL Scores
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: 6 months
SF-36 QoL Scores
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: 1 year
Change in SF-36 QoL Scores From Baseline to 1 Year
Time frame: From baseline to 1 year
SF-36 QoL Scores
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: 24 months
Change in SF-36 QoL Scores From Baseline
Time frame: At 24 months
Number of Participants Undergoing Mitral Valve Surgery
Time frame: Through 5 years
Number of Participants With Additional Mitra Clip Device Intervention
Time frame: Through 5 years
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time frame: 6 months
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time frame: 1 year
Changes in Six Minute Walk Test (6MWT) Distance From Baseline to 1 Year
Time frame: Baseline to 1 year
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time frame: 24 months
Changes in Six Minute Walk Test (6MWT) Distance From Baseline
Time frame: At 24 months
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time frame: 3 years
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time frame: 4 years
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time frame: 5 years
Number of Participants With Mitral Valve Surgery
Surgical access to repair or replace the mitral valve. Measured per occurrence.
Time frame: 30 days
Number of Participants With Mitral Valve Surgery
Surgical access to repair or replace the mitral valve. Measured per occurrence.
Time frame: 1 year
Number of Participants With Additional AVJ-514 Device Intervention
Number of participants with any additional AVJ-514 procedure after the index procedure. Measured per occurrence.
Time frame: 30 days
Number of Participants With Additional AVJ-514 Device Intervention
Number of participants with any additional AVJ-514 procedure after the index procedure. Measured per occurrence.
Time frame: 1 year
Number of Hospitalizations and Reason for Hospitalization
Time frame: 1 year post index procedure
Number of Hospitalizations
Time frame: 24 months
Number of Hospitalizations
Time frame: 3 years
Number of Hospitalizations
Time frame: 4 years
Number of Hospitalizations
Time frame: 5 years
Number of Participants With Mitral Stenosis
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Time frame: 1 year
Mitral Stenosis
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the site.
Time frame: 24 months
Mitral Stenosis
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Time frame: 3 years
Mitral Stenosis
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Time frame: 4 years
Mitral Stenosis
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Time frame: 5 years
Number of Participants With Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Time frame: 12 months
Number of Participants With Clinically Significant ASD That Requires Intervention
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Time frame: 24 months
Number of Participants With Clinically Significant ASD That Requires Intervention
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Time frame: 3 years
Number of Participants With Clinically Significant ASD That Requires Intervention
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Time frame: 4 years
Number of Participants With Clinically Significant ASD That Requires Intervention
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Time frame: 5 years
Number of Participants With Major Bleeding
Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition. Type 3: * Type 3a (i) Overt bleeding plus hemoglobin drop of 3 to \<5 g/dL\* (provided hemoglobin drop is related to bleed) (ii) Any transfusion with overt bleeding * Type 3b (i) Overt bleeding plus hemoglobin drop ≥5 g/dL\* (provided hemoglobin drop is related to bleed) (ii) Cardiac tamponade (iii) Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) (iv) Bleeding requiring intravenous vasoactive agents * Type 3c (i) Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) (ii) Subcategories confirmed by autopsy or imaging or lumbar puncture (iii) Intraocular bleed compromising vision
Time frame: 30 days
Number of Participants With Major Bleeding
Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition. Type 3: * Type 3a (i) Overt bleeding plus hemoglobin drop of 3 to \<5 g/dL\* (provided hemoglobin drop is related to bleed) (ii) Any transfusion with overt bleeding * Type 3b (i) Overt bleeding plus hemoglobin drop ≥5 g/dL\* (provided hemoglobin drop is related to bleed) (ii) Cardiac tamponade (iii) Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) (iv) Bleeding requiring intravenous vasoactive agents * Type 3c (i) Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) (ii) Subcategories confirmed by autopsy or imaging or lumbar puncture (iii) Intraocular bleed compromising vision
Time frame: 1 year
Number of Participants With Usage of Concomitant Cardiac Medications
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)
Number of Participants With Usage of Concomitant Cardiac Medications
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Time frame: 30 days
Number of Participants With Usage of Concomitant Cardiac Medications
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Time frame: 6 months
Number of Participants With Usage of Concomitant Cardiac Medications
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Time frame: 1 year
Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior
Time frame: 1 Year Pre and Post Index Procedure
Number of Participants With Device Embolization Requiring Surgery
Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.
Time frame: 1 year
Number of Participants With Device Embolization Not Requiring Surgery
Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.
Time frame: 1 year
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time frame: 2 year
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time frame: 3 year
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time frame: 4 year