Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 30 days post-implant. MAEs during the first year of post-implant follow-up were adjudicated by a Clinical Events Committee of independent heart specialist physicians.

Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.

Per device analysis

Device success with evidence of mitral regurgitation reduction to ≤ 2+ (mild-moderate) at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.

Participants with procedural success data available after collection of all study data for the Discharge visit.

Procedural success with evidence of MR reduction to ≤ 2+ (mild-moderate) and without MAEs at 30 days. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.

Participants with clinical success data available after collection of all study data for the 30-Day visit.

Mitral regurgitation (MR) severity at 30 days, 6 months, 1 year and annually thereafter. Mitral regurgitation reduction was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.

Participants with an MR severity assessment available after collection of all study data for the visit.

All-cause mortality at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative deaths at each time point.

Recurrent heart failure hospitalization at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative heart failure hospitalizations at each time point.

Reintervention rates for mitral regurgitation at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative reintervention rates at each time point.

Composite of major adverse events (MAEs) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 6 months, 1 year and annually thereafter. The outcome is analyzed as the count and percentage of participants with events at each timepoint.

Left ventricular end diastolic volume (LVEDV) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with an LVEDV measurement available after collection of all study data for the visit.

Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVEDV measurements available for both the Baseline and 6-Month visits after collection of all study data for these visits

Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVEDV measurements available for both the Baseline and 1-Year visits after collection of all study data for these visits

Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVEDV measurements available for both the Baseline and 2-Year visits after collection of all study data for these visits

Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVEDV measurements available for both the Baseline and 3-Year visits after collection of all study data for these visits

Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 4-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVEDV measurements available for both the Baseline and 4-Year visits after collection of all study data for these visits

Left ventricular end systolic volume (LVESV) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with an LVESV measurement available after collection of all study data for the visit.

Change in left ventricular end systolic volume (LVESV) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVESV measurements available for both the Baseline and 6-Month visits after collection of all study data for these visits

Change in left ventricular end systolic volume (LVESV) from the Baseline to the 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVESV measurements available for both the Baseline and 1-Year visits after collection of all study data for these visits

Change in left ventricular end systolic volume (LVESV) from the Baseline to the 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVESV measurements available for both the Baseline and 2-Year visits after collection of all study data for these visits

Change in left ventricular end systolic volume (LVESV) from the Baseline to the 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVESV measurements available for both the Baseline and 3-Year visits after collection of all study data for these visits

Change in left ventricular end systolic volume (LVESV) from the Baseline to the 4-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVESV measurements available for both the Baseline and 4-Year visits after collection of all study data for these visits

Pulmonary artery systolic pressure (PASP) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with a PASP measurement available after collection of all study data for the visit.

Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with PASP measurements available for both the Baseline and 6-Month visits after collection of all study data for these visits

Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with PASP measurements available for both the Baseline and 1-Year visits after collection of all study data for these visits

Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with PASP measurements available for both the Baseline and 2-Year visits after collection of all study data for these visits

Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVESV measurements available for both the Baseline and 3-Year visits after collection of all study data for these visits

Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 4-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with LVESV measurements available for both the Baseline and 4-Year visits after collection of all study data for these visits

Six-minute walk distance (6MWD) by study visit

Participants with a 6MWD measurement available after collection of all study data for the visit

Change in 6-minute walk distance (6MWD) from the Baseline to the 6-Month visit

Participants with 6MWD measurements available for both the Baseline and 6-Month visits after collection of all study data for these visits

Change 6-minute walk distance (6MWD) from the Baseline to the 1-Year visit

Participants with 6MWD measurements available for both the Baseline and 1-Year visits after collection of all study data for these visits

NYHA Functional Classification at 6 months, 1 year and annually thereafter. NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.

The outcome is reported where data are available.

Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ OS) score by study visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.

Participants with a KCCQ OS score value available after collection of all study data for the visit

Change in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ OS) Score from the Baseline to the 30-Day visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.

Participants with KCCQ OS scores available for both the Baseline and 30-Day visits after collection of all study data for these visits

Change in Kansas City Cardiomyopathy Overall Summary (KCCQ OS) score from the Baseline to the 6-Month visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.

Participants with KCCQ OS scores available for both the Baseline and 6-Month visits after collection of all study data for these visits

Change in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ OS) score from the Baseline to the 1-Year visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.

Participants with KCCQ OS scores available for both the Baseline and 1-Year visits after collection of all study data for these visits

EQ5D visual analogue scale (VAS) score by study visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.

Participants with an EQ5D VAS score available after collection of all study data for the visit

Change in EQ5D visual analogue scale (VAS) score from the Baseline to the 30-Day visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.

Participants with EQ5D VAS score values available for both the Baseline and 30-Day visits after collection of all study data for these visits

Change in EQ5D visual analogue scale (VAS) score from the Baseline to the 6-Month visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.

Participants with EQ5D VAS score values available for both the Baseline and 6-Month visits after collection of all study data for these visits.

Change in EQ5D visual analogue scale (VAS) score from the Baseline to the 1-Year visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.

Participants with EQ5D VAS score values available for both the Baseline and 1-Year visits after collection of all study data for these visits.

N-terminal pro-B-type natriuretic peptide (NT-proBNP) level by study visit.

Participants with an NT-proBNP measurement available after collection of all study data for the visit

Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 6-Month visit

Participants with NT-proBNP measurements available for both the Baseline and 6-Month visits after collection of all study data for these visits

Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 1-Year visit

Participants with NT-proBNP measurements available for both the Baseline and 1-Year visits after collection of all study data for these visits

Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 2-Year visit

Participants with NT-proBNP measurements available for both the Baseline and 2-Year visits after collection of all study data for these visits

Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 3-Year visit

Participants with NT-proBNP measurements available for both the Baseline and 3-Year visits after collection of all study data for these visits

Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 4-Year visit

Participants with NT-proBNP measurements available for both the Baseline and 4-Year visits after collection of all study data for these visits

Brain natriuretic peptide (BNP) level by study visit

Participants with a BNP measurement available after collection of all study data for the visit

Change in brain natriuretic peptide (BNP) level from the Baseline to the 6-Month visit

Participants with BNP measurements available for both the Baseline and 6-Month visits after collection of all study data for these visits

Change in brain natriuretic peptide (BNP) level from the Baseline to the 1-Year visit

Participants with BNP measurements available for both the Baseline and 1-Year visits after collection of all study data for these visits

Change in brain natriuretic peptide (BNP) level from the Baseline to the 2-Year visit

Participants with BNP measurements available for both the Baseline and 2-Year visits after collection of all study data for these visits

Change in brain natriuretic peptide (BNP) level from the Baseline to the 3-Year visit

Participants with BNP measurements available for both the Baseline and 3-Year visits after collection of all study data for these visits

Change in brain natriuretic peptide (BNP) level from the Baseline to the 4-Year visit

Participants with BNP measurements available for both the Baseline and 4-Year visits after collection of all study data for these visits

Change in tricuspid regurgitation (TR) severity grade from the Baseline visit. TR severity was graded on a 5-point scale (none/trace, mild, mild-moderate, moderate-severe, severe) by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging.

Participants with TR severity grades available for both the Baseline and follow-up visit after collection of all study data for these visits.

Mitral effective regurgitant orifice area (EROA) by study visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with a mitral EROA measurement available after collection of all study data for the visit

Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 30-Day visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral EROA measurements available for both the Baseline and 30-Day visits after collection of all study data for these visits

Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 6-Month visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral EROA measurements available for both the Baseline and 6-Month visits after collection of all study data for these visits

Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 1-Year visit, , measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral EROA measurements available for both the Baseline and 1-Year visits after collection of all study data for these visits

Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 2-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral EROA measurements available for both the Baseline and 2-Year visits after collection of all study data for these visits

Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 3-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral EROA measurements available for both the Baseline and 3-Year visits after collection of all study data for these visits

Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 4-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral EROA measurements available for both the Baseline and 4-Year visits after collection of all study data for these visits

Mitral regurgitant volume by study visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with a mitral regurgitant volume measurement available after collection of all study data for the visit

Change in mitral regurgitant volume from the Baseline to the 30-Day visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral regurgitant volume measurements available for both the Baseline and 30-Day visits after collection of all study data for these visits

Change in mitral regurgitant volume from the Baseline to the 6-Month visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral regurgitant volume measurements available for both the Baseline and 6-Month visits after collection of all study data for these visits

Change in mitral regurgitant volume from the Baseline to the 1-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral regurgitant volume measurements available for both the Baseline and 1-Year visits after collection of all study data for these visits

Change in mitral regurgitant volume from the Baseline to the 2-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral regurgitant volume measurements available for both the Baseline and 2-Year visits after collection of all study data for these visits

Change in mitral regurgitant volume from the Baseline to the 3-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral regurgitant volume measurements available for both the Baseline and 3-Year visits after collection of all study data for these visits

Change in mitral regurgitant volume from the Baseline to the 4-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Participants with mitral regurgitant volume measurements available for both the Baseline and 4-Year visits after collection of all study data for these visits