EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.
Prospective, multi-center, randomized study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant). A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II RCT. 38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM. The RCT is powered to test the hypothesis MitraClip has both superiority of safety and non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
279
MitraClip Implant
Repair or replacement of mitral valve
Evanston Northwestern Healthcare
Evanston, Illinois, United States
Number of Participants With Major Adverse Events (MAE)
Defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Time frame: 30 days
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Time frame: 12 months
Freedom From All-Cause Mortality
Time frame: 12 months
Freedom From All-Cause Mortality
Time frame: 24 months
Freedom From All-Cause Mortality
Time frame: 3 years
Freedom From All-Cause Mortality
Time frame: 4 years
Freedom From All-Cause Mortality
Time frame: 5 years
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.
Time frame: 12 months
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Time frame: 24 months
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort
Time frame: 24 months
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Time frame: At discharge (≤ 14 days following index procedure) or 30 days
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Time frame: 12 months
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Time frame: 24 months
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Time frame: 3 years
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Time frame: 4 years
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Time frame: 5 years
Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)
Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Time frame: 30 days
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.
Time frame: 12 months
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.
Time frame: 24 months
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 3 years.
Time frame: 3 years
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 4 years
Time frame: 4 years
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 5 years.
Time frame: 5 years
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time frame: 30 days
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time frame: 12 months
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time frame: 2 years
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time frame: 3 years
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time frame: 4 years
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time frame: 5 years
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.
Time frame: 30 days
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.
Time frame: 12 months
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.
Time frame: 24 months
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.
Time frame: 3 years
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.
Time frame: 4 years
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.
Time frame: 5 years
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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. They 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: Baseline
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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. They 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 New York Heart Association (NYHA) Functional Class Cardiac Disease.
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. They 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: 12 months
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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. They 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
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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. They 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
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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. They 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
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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. They 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
New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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. They 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
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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. They 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: 12 months
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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. They 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: 2 years
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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. They 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
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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. They 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
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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. They 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
Short Form (SF)-36 Quality of Life Questionnaire.
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) \& mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, \& general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL\&100% indicates full QOL).Higher scores represent better self-perceived health. 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
Short Form (SF)-36 Quality of Life Questionnaire.
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) \& mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, \& general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL\&100% indicates full QOL).Higher scores represent better self-perceived health. 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: 12 months
Cardiac Output
Cardiac output as measured by core lab echocardiography.
Time frame: 30 days
Cardiac Output
Cardiac output as measured by core lab echocardiography.
Time frame: 12 months
Cardiac Output
Cardiac output as measured by core lab echocardiography.
Time frame: 24 months
Cardiac Index
Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Time frame: 30 days
Cardiac Index (CI)
Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.
Time frame: 12 months
Cardiac Index
Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Time frame: 24 months
Regurgitant Volume
Regurgitant volume as determined by the core echo laboratory. 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
Regurgitant volume as determined by the core echo laboratory.
Time frame: 12 months
Regurgitant Volume
Regurgitant volume as determined by the core echo laboratory.
Time frame: 24 months
Regurgitant Fraction (RF)
RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time frame: 30 Days
Regurgitant Fraction
Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time frame: 12 months
Regurgitant Fraction
Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time frame: 24 months
Number of Participants With Clip Implant Rate
Defined as the rate of successful implantation of MitraClip(s).
Time frame: Day 0
Number of Participants With Acute Procedural Success
Defined as successful MitraClip implantation with resulting MR of 2+ or less.
Time frame: 30 Days
Number of Participants With Acute Surgical Success
Defined as successful mitral valve repair or replacement surgery.
Time frame: 30 Days
Number of Participants With Successful Clip Implant and Acute Procedural Success
Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.
Time frame: 30 days
Number of Participants With Mitral Valve Repair Success.
Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR \> 2+ at 12 months.
Time frame: 12 months
Number of Participants With Mitral Valve Repair Success.
Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR \> 2+ at 12 months.
Time frame: 24 months
Number of Participants With Procedural Freedom From In-hospital MAE.
Time frame: Day 0
Number of Participants With Procedural Freedom From In-hospital MAE
Time frame: Day 30
Number of Participants With MAE: Surgery After Device and First Time Surgery Control
Time frame: 30 days
Number of Participants With Major Vascular Complications
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer: * Hematoma at access site \>6 cm; * Retroperitoneal hematoma; * Arteriovenous (AV) fistula; * Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting \>48 hours; * Vascular Surgical Repair at catheter access sites; * Pulmonary embolism; * Ipsilateral deep vein thrombus; or * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Time frame: 30 days
Number of Participants With Major Vascular Complications
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer: * Hematoma at access site \>6 cm; * Retroperitoneal hematoma; * Arteriovenous (AV) fistula; * Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting \>48 hours; * Vascular Surgical Repair at catheter access sites; * Pulmonary embolism; * Ipsilateral deep vein thrombus; or * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Time frame: 12 months
Number of Participants With Major Bleeding Complications.
Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.
Time frame: 30 days
Number of Participants With Major Bleeding Complications.
Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 12 months.
Time frame: 12 months
Number of Participants With Major Adverse Events (MAE)
Time frame: 12 months.
Number of Participants With MAE in Patients Over 75 Years of Age.
Time frame: 30 days
Number of Participants With MAE in Patients Over 75 Years of Age.
Time frame: 12 months
Number of Participants With Dysrhythmia
Time frame: 30 days
Number of Participants With Dysrhythmia
Time frame: 12 months
Number of Participants With Endocarditis.
Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Time frame: 30 days
Number of Participants With Endocarditis.
Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Time frame: 12 months
Number of Participants With Thrombosis.
Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
Time frame: 30 days
Number of Participants With Thrombosis.
Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
Time frame: 12 months
Number of Participants With Hemolysis
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below: Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.
Time frame: 30 days
Number of Participants With Hemolysis
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below: Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.
Time frame: 12 months
Number of Participants With Clinically Significant Atrial Septal Defect (ASD).
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Time frame: 30 days
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Time frame: 12 months
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography.
Time frame: 30 days
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography.
Time frame: 12 months
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography.
Time frame: 24 months
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area \< 1.5 cm\^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time frame: 3 years
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area \< 1.5 cm\^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time frame: 4 years
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area \< 1.5 cm\^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time frame: 5 years
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: At Discharge (≤14 days of index procedure)
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: 30 Days
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: 12 months
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: 24 months
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: 3 years
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: 4 years
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: 5 years
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time frame: 30 Days
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time frame: 12 months
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time frame: 24 months
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: At Discharge (≤14 days of index procedure)
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: 30 days
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: 12 months
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: 24 months
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: 3 years
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: 4 years
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: 5 years
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time frame: 30 Days
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time frame: 12 months
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time frame: 24 months
Transvalvular Mitral Valve Gradient
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time frame: At Discharge (≤ 14 days following index procedure)
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).
Time frame: 12 months
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time frame: 24 months
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time frame: 3 year
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time frame: 4 year
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time frame: 5 years
Post-procedure Length of Hospital Stay
Time frame: 30 Days
Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration
Time frame: 30 Days
Number of Participants With Hospital Re-admissions
Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups.
Time frame: 30 days
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital
Time frame: 30 Days
Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).
Time frame: 30 days
Number of Participants With New Coumadin (Warfarin) Usage
Time frame: 30 days
Number of Participants With New Coumadin (Warfarin) Usage
Time frame: 12 months
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval.
Time frame: 12 months
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval.
Time frame: 12-18 months
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval.
Time frame: 18-24 months
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval.
Time frame: 24 months-3 year
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR \> 2+
Time frame: 12 months
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR \> 2+
Time frame: 24 months
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR \> 2+
Time frame: 3 years
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time frame: 12 months
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time frame: 24 months
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time frame: 3 years
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time frame: 4 years
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time frame: 5 years
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time frame: 12 months
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time frame: 24 months
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time frame: 3 years
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time frame: 4 years
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time frame: 5 years
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.
Time frame: 12 months
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time frame: 12 months to 3 years
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time frame: 12 months to 4 years
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time frame: 12 months to 5 years
Number of Participants With Non-cerebral Thromboembolism.
Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Time frame: 12 months
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe. "Discharge" refers to each individual patient's date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable.
Time frame: 30 days
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time frame: 12 months
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time frame: 24 months
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time frame: 3 years
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time frame: 4 years
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time frame: 5 years
Number of Participants With Non-cerebral Thromboembolism.
Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Time frame: 30 days
Number of Participants With Incidence of Mitral Valve Replacement
Time frame: 12 months
Number of Participants With Incidence of Mitral Valve Replacement
Time frame: 24 months
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