Real World Expanded Multicenter Study of the MitraClip® System (REALISM)

Number of Participants With Serious Adverse Events

The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.

Time frame: 30 days

Number of Participants With Serious Adverse Events

The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.

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 Major Adverse Events (MAE) in Patients Over 75 Years of Age

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Time frame: 30 days

Number of Participants With Major Adverse Events in Patients Over 75 Years of Age

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Time frame: 12 Months

Number of Participants With Major Adverse Events in Patients Over 75 Years of Age

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Time frame: 2 years

Number of Participants With Major Adverse Events in Patients Over 75 Years of Age

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Time frame: 3 years

Number of Participants With Major Adverse Events in Patients Over 75 Years of Age

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Time frame: 4 years

Number of Participants With Major Adverse Events in Patients Over 75 Years of Age

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Time frame: 5 years

Number of Participants With Acute Procedural Success

Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip.

Time frame: At discharge (an average of ≤ 12.3 days post-index procedure)

Number of Participants With Procedural Success

Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.

Time frame: 30 days

Number of Participants With Clinical Durability

Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months.

Time frame: 12 months

Number of Participants With Clip Implant Rate

Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.

Time frame: On the day of index procedure (≤1 day)

Procedure Time

The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed.

Time frame: On the day of index procedure

Device Time

Device time is defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip delivery catheter is retracted into the SGC.

Time frame: On the day of index procedure

Fluoroscopy Duration

Mean fluoroscopy duration during the MitraClip procedure.

Time frame: On the day of index procedure

Number of Participants With MitraClip Devices Implanted

The distribution of number of MitraClip devices implanted in patients.

Time frame: On the day of index procedure

Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration

Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.

Time frame: At discharge (an average of ≤ 12.3 days post-index procedure).

Post-Procedure Length of Hospital Stay

Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.

Time frame: At discharge (an average of ≤ 12.3 days post-index procedure).

Number of Participants Experiencing Death

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Time frame: 12 months visit window (410 days)

Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility

Time frame: At discharge (an average of ≤ 12.3 days post-index procedure)

Number of Participants With Hospital Re-admissions

Defined as re-admission of patients to the hospital following discharge from the Clip procedure.

Time frame: 30 days

Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Time frame: 0 to 5 years

Number of Participants With Mitral Stenosis

Mitral stenosis is a key safety consideration assessed after implantation of the MitraClip device. It is defined as Mitral Valve Area (MVA) less than 1.5 cm\^2 as assessed by the Echocardiography Core Laboratory (ECL).

Time frame: 0 to 5 years

Number of Participants With Mitral Regurgitation (MR) Severity

Paired site-assessed Mitral regurgitation severity between baseline and 30 days using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Time frame: 30 days(Follow-up)

Number of Participants With MR Severity

Paired site-assessed Mitral regurgitation severity between baseline and 12 months using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Time frame: 12 months

Number of Participants With MR Severity

Paired site-assessed Mitral regurgitation severity between baseline and 2 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Time frame: 2 years

Number of Participants With MR Severity

Paired site-assessed Mitral regurgitation severity between baseline and 3 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Time frame: 3 years

Number of Participants With MR Severity

Paired site-assessed Mitral regurgitation severity between baseline and 4 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Time frame: 4 years

Number of Participants With MR Severity

Paired site-assessed Mitral regurgitation severity between baseline and 5 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Time frame: 5 years

Number of Participants With Second Intervention to Place an Additional Mitraclip Device.

If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.

Time frame: 139 days post the index procedure

Number of Participants With Second Intervention to Place an Additional Mitraclip Device.

If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.

Time frame: 5 years

Number of Participants With New York Heart Association (NYHA) Functional Class

Paired NYHA data from baseline to 30 days. 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 NYHA Functional Class

Paired NYHA data from baseline to 12 months. 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 NYHA Functional Class

Paired NYHA data from baseline to 2 years. 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

Number of Participants With NYHA Functional Class

Paired NYHA data from baseline to 3 years. 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 NYHA Functional Class

Paired NYHA data from baseline to 4 years. 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 NYHA Functional Class

Paired NYHA data from baseline to 5 years. 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

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to discharge or 30 days as determined by echo core laboratory.

Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 12 months as determined by echo core laboratory.

Time frame: 12 months

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 24 months as determined by echo core laboratory.

Time frame: 24 months

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 36 months as determined by echo core laboratory.

Time frame: 36 months

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 48 months as determined by the echo core laboratory.

Time frame: 48 months

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 60 months as determined by echo core laboratory.

Time frame: 60 months

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to discharge or 30 days as determined by echo core laboratory.

Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 12 months as determined by echo core laboratory.

Time frame: 12 months

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 24 months as determined by echo core laboratory.

Time frame: 24 months

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 36 months as determined by echo core laboratory.

Time frame: 36 months

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 48 months as determined by echo core laboratory.

Time frame: 48 months

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 60 months as determined by echo core laboratory.

Time frame: 60 months

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to discharge or 30 days as determined by echo core laboratory.

Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 12 months as determined by echo core laboratory.

Time frame: 12 months

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 24 months as determined by echo core laboratory.

Time frame: 24 months

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 36 months as determined by echo core laboratory.

Time frame: 36 months

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 48 months as determined by echo core laboratory.

Time frame: 48 months

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 60 months as determined by echo core laboratory.

Time frame: 60 months

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to discharge or 30 days as determined by echo core laboratory.

Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 12 months as determined by echo core laboratory.

Time frame: 12 months

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 24 months as determined by echo core laboratory.

Time frame: 24 months

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 36 months as determined by echo core laboratory.

Time frame: 36 months

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 48 months as determined by echo core laboratory.

Time frame: 48 months

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 60 months as determined by echo core laboratory.

Time frame: 60 months

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to discharge or 30 days as determined by echo core laboratory.

Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 12 months as determined by echo core laboratory.

Time frame: 12 months

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 24 months as determined by echo core laboratory.

Time frame: 24 months

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 36 months as determined by echo core laboratory.

Time frame: 36 months

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 48 months as determined by echo core laboratory.

Time frame: 48 months

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 60 months as determined by echo core laboratory.

Time frame: 60 months

Septal-Lateral Annular Dimension Diastole (SLADd)

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to discharge or 30 days as determined by echo core laboratory.

Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Septal-Lateral Annular Dimension Diastole (SLADd)

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 12 months as determined by echo core laboratory.

Time frame: 12 months

Septal-Lateral Annular Dimension Diastole (SLADd)

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 24 months as determined by echo core laboratory.

Time frame: 24 months

Septal-Lateral Annular Dimension Diastole (SLADd)

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 36 months as determined by echo core laboratory.

Time frame: 36 months

Septal-Lateral Annular Dimension Diastole (SLADd)

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 48 months as determined by echo core laboratory.

Time frame: 48 months

Septal-Lateral Annular Dimension Diastole (SLADd)

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 60 months as determined by echo core laboratory.

Time frame: 60 months

Septal-Lateral Annular Dimension Systole (SLADs)

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to discharge or 30 days as determined by echo core laboratory.

Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Septal-Lateral Annular Dimension Systole (SLADs)

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 12 months as determined by echo core laboratory.

Time frame: 12 months

Septal-Lateral Annular Dimension Systole (SLADs)

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 24 months as determined by echo core laboratory.

Time frame: 24 months

Septal-Lateral Annular Dimension Systole (SLADs)

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 36 months as determined by echo core laboratory.

Time frame: 36 months

Septal-Lateral Annular Dimension Systole (SLADs)

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 48 months as determined by echo core laboratory.

Time frame: 48 months

Septal-Lateral Annular Dimension Systole (SLADs)

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 60 months as determined by echo core laboratory.

Time frame: 60 months