Trial Outcomes & Findings for The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study (NCT NCT03170349)

NCT ID: NCT03170349

Last Updated: 2026-02-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 124 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2026-02-05

Participant Flow

Participant milestones

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System Mitral valve repair with PASCAL implanted via transcatheter procedure
At 30 Days Follow-up (±7 Days Window) STARTED	124
At 30 Days Follow-up (±7 Days Window) COMPLETED	123
At 30 Days Follow-up (±7 Days Window) NOT COMPLETED	1
At 6 Months Follow-up (±30 Days Window) STARTED	123
At 6 Months Follow-up (±30 Days Window) COMPLETED	114
At 6 Months Follow-up (±30 Days Window) NOT COMPLETED	9
At 1 Year Follow-up (±45 Days Window) STARTED	114
At 1 Year Follow-up (±45 Days Window) COMPLETED	106
At 1 Year Follow-up (±45 Days Window) NOT COMPLETED	8
At 2 Year Follow-up (±45 Days Window) STARTED	106
At 2 Year Follow-up (±45 Days Window) COMPLETED	88
At 2 Year Follow-up (±45 Days Window) NOT COMPLETED	18
At 3 Year Follow-up (±45 Days Window) STARTED	92
At 3 Year Follow-up (±45 Days Window) COMPLETED	76
At 3 Year Follow-up (±45 Days Window) NOT COMPLETED	16
At 4-year Follow-up (±45 Days Window) STARTED	78
At 4-year Follow-up (±45 Days Window) COMPLETED	61
At 4-year Follow-up (±45 Days Window) NOT COMPLETED	17

Reasons for withdrawal

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System Mitral valve repair with PASCAL implanted via transcatheter procedure
At 30 Days Follow-up (±7 Days Window) Death	1
At 6 Months Follow-up (±30 Days Window) Death	3
At 6 Months Follow-up (±30 Days Window) Withdrawal by Subject	1
At 6 Months Follow-up (±30 Days Window) Exited for Other Reasons	5
At 1 Year Follow-up (±45 Days Window) Death	6
At 1 Year Follow-up (±45 Days Window) Exited for Other Reasons	2
At 2 Year Follow-up (±45 Days Window) Death	13
At 2 Year Follow-up (±45 Days Window) Withdrawal by Subject	1
At 2 Year Follow-up (±45 Days Window) Missed Visit	4
At 3 Year Follow-up (±45 Days Window) Death	10
At 3 Year Follow-up (±45 Days Window) Lost to Follow-up	2
At 3 Year Follow-up (±45 Days Window) Withdrawal by Subject	2
At 3 Year Follow-up (±45 Days Window) Missed Visit	2
At 4-year Follow-up (±45 Days Window) Death	13
At 4-year Follow-up (±45 Days Window) Missed Visit	2
At 4-year Follow-up (±45 Days Window) Exited for Other Reasons	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Age, Continuous	74.9 years STANDARD_DEVIATION 11.2 • n=124 Participants
Sex: Female, Male Female	55 Participants n=124 Participants
Sex: Female, Male Male	69 Participants n=124 Participants
Height	66.7 inches STANDARD_DEVIATION 4.1 • n=124 Participants
Weight	165.4 pounds STANDARD_DEVIATION 34.0 • n=124 Participants
Body Mass Index	26.2 kilogram/meter square STANDARD_DEVIATION 4.9 • n=124 Participants
Tobacco Use Current daily smoker	4 Participants n=124 Participants
Tobacco Use Former daily smoker	63 Participants n=124 Participants
Tobacco Use Never	57 Participants n=124 Participants
EuroSCORE II	5.8 Units on a scale STANDARD_DEVIATION 5.4 • n=116 Participants • Data unavailable for 8 patients.
STS Mortality Score	4.6 Units on a scale STANDARD_DEVIATION 3.3 • n=124 Participants
NYHA Class Class I	0 Participants n=123 Participants • Data unavailable for 1 patient.
NYHA Class Class II	49 Participants n=123 Participants • Data unavailable for 1 patient.
NYHA Class Class III	68 Participants n=123 Participants • Data unavailable for 1 patient.
NYHA Class Class IV	6 Participants n=123 Participants • Data unavailable for 1 patient.

PRIMARY outcome

Timeframe: 30 days

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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Number of Participants With Major Adverse Events (MAE)	10 Participants

PRIMARY outcome

Timeframe: Exit from the cardiac catheterization laboratory

Population: Per device analysis

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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=189 Device Mitral valve repair with PASCAL implanted via transcatheter procedure
Device Success	175 Device

PRIMARY outcome

Timeframe: through discharge

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

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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=122 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Number of Participants With Procedural Success	115 Participants

PRIMARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=121 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Clinical Success	105 Participants

SECONDARY outcome

Timeframe: Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Mitral Regurgitation Reduction 30 Days · Severe (4+)	2 Participants
Mitral Regurgitation Reduction 6 Months · None/Trace (0+)	17 Participants
Mitral Regurgitation Reduction 6 Months · Mild (1+)	64 Participants
Mitral Regurgitation Reduction 6 Months · Mild-Moderate (2+)	28 Participants
Mitral Regurgitation Reduction 6 Months · Moderate-Severe (3+)	2 Participants
Mitral Regurgitation Reduction 6 Months · Severe (4+)	0 Participants
Mitral Regurgitation Reduction 1 Year · None/Trace (0+)	13 Participants
Mitral Regurgitation Reduction 1 Year · Mild (1+)	57 Participants
Mitral Regurgitation Reduction 1 Year · Mild-Moderate (2+)	22 Participants
Mitral Regurgitation Reduction 1 Year · Moderate-Severe (3+)	0 Participants
Mitral Regurgitation Reduction 1 Year · Severe (4+)	0 Participants
Mitral Regurgitation Reduction 2 Years · None/Trace (0+)	11 Participants
Mitral Regurgitation Reduction 2 Years · Mild (1+)	40 Participants
Mitral Regurgitation Reduction 2 Years · Mild-Moderate (2+)	18 Participants
Mitral Regurgitation Reduction 2 Years · Moderate-Severe (3+)	2 Participants
Mitral Regurgitation Reduction 2 Years · Severe (4+)	0 Participants
Mitral Regurgitation Reduction 3 Years · None/Trace (0+)	10 Participants
Mitral Regurgitation Reduction 3 Years · Mild (1+)	32 Participants
Mitral Regurgitation Reduction 3 Years · Mild-Moderate (2+)	14 Participants
Mitral Regurgitation Reduction 3 Years · Moderate-Severe (3+)	3 Participants
Mitral Regurgitation Reduction 3 Years · Severe (4+)	0 Participants
Mitral Regurgitation Reduction 4 Years · None/Trace (0+)	9 Participants
Mitral Regurgitation Reduction 4 Years · Mild (1+)	28 Participants
Mitral Regurgitation Reduction 4 Years · Mild-Moderate (2+)	5 Participants
Mitral Regurgitation Reduction 4 Years · Moderate-Severe (3+)	2 Participants
Mitral Regurgitation Reduction 4 Years · Severe (4+)	1 Participants
Mitral Regurgitation Reduction 30 Days · Mild-Moderate (2+)	23 Participants
Mitral Regurgitation Reduction 30 Days · Moderate-Severe (3+)	2 Participants
Mitral Regurgitation Reduction Baseline · None/Trace (0+)	0 Participants
Mitral Regurgitation Reduction Baseline · Mild (1+)	1 Participants
Mitral Regurgitation Reduction Baseline · Mild-Moderate (2+)	0 Participants
Mitral Regurgitation Reduction Baseline · Moderate-Severe (3+)	66 Participants
Mitral Regurgitation Reduction Baseline · Severe (4+)	57 Participants
Mitral Regurgitation Reduction 30 Days · None/Trace (0+)	18 Participants
Mitral Regurgitation Reduction 30 Days · Mild (1+)	72 Participants

SECONDARY outcome

Timeframe: 30 days, 6 months, 1 year, 2 years, 3 years, 4 Years

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
All-cause Mortality 30 days	1 Participants
All-cause Mortality 6 months	4 Participants
All-cause Mortality 1 year	10 Participants
All-cause Mortality 2 years	23 Participants
All-cause Mortality 3 years	31 Participants
All-cause Mortality 4 years	45 Participants

SECONDARY outcome

Timeframe: 30 days , 6 months, 1 year, 2 year, 3 year, 4 year

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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Recurrent Heart Failure Hospitalization 30 days	3 Participants
Recurrent Heart Failure Hospitalization 6 months	10 Participants
Recurrent Heart Failure Hospitalization 1 year	15 Participants
Recurrent Heart Failure Hospitalization 2 year (site-reported)	23 Participants
Recurrent Heart Failure Hospitalization 3 year (site-reported)	29 Participants
Recurrent Heart Failure Hospitalization 4 years (site-reported)	33 Participants

SECONDARY outcome

Timeframe: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year

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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Reintervention Rates for Mitral Regurgitation 30 days	1 Participants
Reintervention Rates for Mitral Regurgitation 6 months	2 Participants
Reintervention Rates for Mitral Regurgitation 1 year	2 Participants
Reintervention Rates for Mitral Regurgitation 2 year (site-reported)	3 Participants
Reintervention Rates for Mitral Regurgitation 3 year (site-reported)	4 Participants
Reintervention Rates for Mitral Regurgitation 4 years (site-reported)	6 Participants

SECONDARY outcome

Timeframe: 6 months, 1 year, 2 year, 3 year, 4 year

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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Composite of Major Adverse Events (MAEs) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Reintervention for Study Device Related Complications. 6 months	16 Participants
Composite of Major Adverse Events (MAEs) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Reintervention for Study Device Related Complications. 1 year	23 Participants
Composite of Major Adverse Events (MAEs) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Reintervention for Study Device Related Complications. 2 year (site-reported)	26 Participants
Composite of Major Adverse Events (MAEs) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Reintervention for Study Device Related Complications. 3 year (site-reported)	33 Participants
Composite of Major Adverse Events (MAEs) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Reintervention for Study Device Related Complications. 4 years (site-reported)	45 Participants

SECONDARY outcome

Timeframe: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

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

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=108 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
LVEDV by Study Visit Baseline Visit	181.2 milliliters Standard Deviation 60.8
LVEDV by Study Visit 6-Month Visit	166.2 milliliters Standard Deviation 61.3
LVEDV by Study Visit 1-Year Visit	152.8 milliliters Standard Deviation 55.6
LVEDV by Study Visit 2-Year Visit	145.9 milliliters Standard Deviation 58.5
LVEDV by Study Visit 3-Year Visit	151.3 milliliters Standard Deviation 66.1
LVEDV by Study Visit 4-Year Visit	141.2 milliliters Standard Deviation 63.3

SECONDARY outcome

Timeframe: Baseline and 6 Months

Population: 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 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=86 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in LVEDV, Baseline to 6-Month Visit Baseline Visit	187.3 milliliters Standard Deviation 60.9
Change in LVEDV, Baseline to 6-Month Visit 6-Month Visit	169.9 milliliters Standard Deviation 61.1
Change in LVEDV, Baseline to 6-Month Visit Change from Baseline	-17.4 milliliters Standard Deviation 30.5

SECONDARY outcome

Timeframe: Baseline and 1 Year

Population: 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 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=73 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in LVEDV, Baseline to 1-Year Visit Baseline Visit	178.0 milliliters Standard Deviation 61.5
Change in LVEDV, Baseline to 1-Year Visit 1-Year Visit	153.3 milliliters Standard Deviation 54.3
Change in LVEDV, Baseline to 1-Year Visit Change from Baseline	-24.6 milliliters Standard Deviation 34.8

SECONDARY outcome

Timeframe: Baseline and 2 Years

Population: 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 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=60 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in LVEDV, Baseline to 2-Year Visit 2-Year Visit	153.0 milliliters Standard Deviation 57.6
Change in LVEDV, Baseline to 2-Year Visit Change from Baseline	-29.1 milliliters Standard Deviation 38.3
Change in LVEDV, Baseline to 2-Year Visit Baseline Visit	182.1 milliliters Standard Deviation 64.0

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=47 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in LVEDV, Baseline to 3-Year Visit Baseline Visit	187.6 milliliters Standard Deviation 66.0
Change in LVEDV, Baseline to 3-Year Visit 3-Year Visit	161.5 milliliters Standard Deviation 64.7
Change in LVEDV, Baseline to 3-Year Visit Change from Baseline	-26.1 milliliters Standard Deviation 38.2

SECONDARY outcome

Timeframe: Baseline and 4 Years

Population: Participants with LVEDV measurements available for both the Baseline and 4-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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=38 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in LVEDV, Baseline to 4-Year Visit Baseline Visit	174.2 milliliters Standard Deviation 64.6
Change in LVEDV, Baseline to 4-Year Visit 4-Year Visit	147.6 milliliters Standard Deviation 64.9
Change in LVEDV, Baseline to 4-Year Visit Change from Baseline	-26.6 milliliters Standard Deviation 33.6

SECONDARY outcome

Timeframe: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

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

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=108 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
LVESV by Study Visit 6-Month Visit	100.6 milliliters Standard Deviation 54.0
LVESV by Study Visit 1-Year Visit	91.1 milliliters Standard Deviation 49.4
LVESV by Study Visit 2-Year Visit	86.0 milliliters Standard Deviation 51.7
LVESV by Study Visit 3-Year Visit	91.9 milliliters Standard Deviation 57.7
LVESV by Study Visit 4-Year Visit	82.3 milliliters Standard Deviation 54.9
LVESV by Study Visit Baseline Visit	108.7 milliliters Standard Deviation 55.1

SECONDARY outcome

Timeframe: Baseline and 6 Months

Population: 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 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=86 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in LVESV, Baseline to 6-Month Visit Baseline Visit	112.6 milliliters Standard Deviation 56.5
Change in LVESV, Baseline to 6-Month Visit 6-Month Visit	103.2 milliliters Standard Deviation 54.2
Change in LVESV, Baseline to 6-Month Visit Change from Baseline	-9.3 milliliters Standard Deviation 22.5

SECONDARY outcome

Timeframe: Baseline and 1 Year

Population: 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 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=73 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in LVESV, Baseline to 1-Year Visit Baseline Visit	104.6 milliliters Standard Deviation 54.9
Change in LVESV, Baseline to 1-Year Visit 1-Year Visit	90.8 milliliters Standard Deviation 48.1
Change in LVESV, Baseline to 1-Year Visit Change from Baseline	-13.7 milliliters Standard Deviation 27.0

SECONDARY outcome

Timeframe: Baseline and 2 Years

Population: 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 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=60 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in LVESV, Baseline to 2-Year Visit Baseline Visit	109.6 milliliters Standard Deviation 59.1
Change in LVESV, Baseline to 2-Year Visit 2-Year Visit	91.6 milliliters Standard Deviation 51.7
Change in LVESV, Baseline to 2-Year Visit Change from Baseline	-18.0 milliliters Standard Deviation 30.0

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=47 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in LVESV, Baseline to 3-Year Visit Baseline Visit	114.5 milliliters Standard Deviation 60.1
Change in LVESV, Baseline to 3-Year Visit 6-Month Visit	100.2 milliliters Standard Deviation 57.4
Change in LVESV, Baseline to 3-Year Visit Change from Baseline	-14.4 milliliters Standard Deviation 28.9

SECONDARY outcome

Timeframe: Baseline and 4 Years

Population: Participants with LVESV measurements available for both the Baseline and 4-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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=38 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in LVESV, Baseline to 4-Year Visit Baseline Visit	101.7 milliliters Standard Deviation 59.2
Change in LVESV, Baseline to 4-Year Visit 4-Year Visit	88.1 milliliters Standard Deviation 56.9
Change in LVESV, Baseline to 4-Year Visit Change from Baseline	-13.6 milliliters Standard Deviation 30.4

SECONDARY outcome

Timeframe: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

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

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=112 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
PASP by Study Visit Baseline Visit	46.4 millimeters of mercury (mmHg) Standard Deviation 12.6
PASP by Study Visit 6-Month Visit	39.7 millimeters of mercury (mmHg) Standard Deviation 11.2
PASP by Study Visit 1-Year Visit	39.9 millimeters of mercury (mmHg) Standard Deviation 11.6
PASP by Study Visit 2-Year Visit	37.2 millimeters of mercury (mmHg) Standard Deviation 11.9
PASP by Study Visit 3-Year Visit	39.8 millimeters of mercury (mmHg) Standard Deviation 12.2
PASP by Study Visit 4-Year Visit	39.6 millimeters of mercury (mmHg) Standard Deviation 14.1

SECONDARY outcome

Timeframe: Baseline and 6 Months

Population: 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 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=89 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in PASP, Baseline to 6-Month Visit Baseline Visit	46.0 millimeters of mercury (mmHg) Standard Deviation 12.0
Change in PASP, Baseline to 6-Month Visit 6-Month Visit	40.2 millimeters of mercury (mmHg) Standard Deviation 11.0
Change in PASP, Baseline to 6-Month Visit Change from Baseline	-5.8 millimeters of mercury (mmHg) Standard Deviation 12.0

SECONDARY outcome

Timeframe: Baseline and 1 Year

Population: 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 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=74 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in PASP, Baseline to 1-Year Visit Baseline Visit	46.4 millimeters of mercury (mmHg) Standard Deviation 11.9
Change in PASP, Baseline to 1-Year Visit 1-Year Visit	40.2 millimeters of mercury (mmHg) Standard Deviation 11.5
Change in PASP, Baseline to 1-Year Visit Change from Baseline	-6.2 millimeters of mercury (mmHg) Standard Deviation 12.9

SECONDARY outcome

Timeframe: Baseline and 2 Years

Population: 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 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=53 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in PASP, Baseline to 2-Year Visit Baseline Visit	45.0 millimeters of mercury (mmHg) Standard Deviation 12.2
Change in PASP, Baseline to 2-Year Visit 2-Year Visit	38.0 millimeters of mercury (mmHg) Standard Deviation 11.9
Change in PASP, Baseline to 2-Year Visit Change from Baseline	-6.9 millimeters of mercury (mmHg) Standard Deviation 13.8

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=50 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in PASP, Baseline to 3-Year Visit Baseline Visit	44.2 millimeters of mercury (mmHg) Standard Deviation 12.1
Change in PASP, Baseline to 3-Year Visit 6-Month Visit	40.4 millimeters of mercury (mmHg) Standard Deviation 12.0
Change in PASP, Baseline to 3-Year Visit Change from Baseline	-3.8 millimeters of mercury (mmHg) Standard Deviation 14.9

SECONDARY outcome

Timeframe: Baseline and 4 Years

Population: Participants with LVESV measurements available for both the Baseline and 4-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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=36 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in PASP, Baseline to 4-Year Visit Baseline Visit	43.6 millimeters of mercury (mmHg) Standard Deviation 13.8
Change in PASP, Baseline to 4-Year Visit 4-Year Visit	40.7 millimeters of mercury (mmHg) Standard Deviation 14.3
Change in PASP, Baseline to 4-Year Visit Change from Baseline	-2.8 millimeters of mercury (mmHg) Standard Deviation 16.1

SECONDARY outcome

Timeframe: Baseline, 6 Months and 1 Year

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

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
6MWD by Study Visit 6-Month Visit	290.8 meters Standard Deviation 103.3
6MWD by Study Visit 1-Year Visit	312.4 meters Standard Deviation 104.1
6MWD by Study Visit Baseline Visit	265.4 meters Standard Deviation 86.6

SECONDARY outcome

Timeframe: Baseline and 6 Months

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

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=104 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in 6MWD, Baseline to 6-Month Visit Baseline Visit	273.2 meters Standard Deviation 87.5
Change in 6MWD, Baseline to 6-Month Visit 6-Month Visit	290.8 meters Standard Deviation 103.3
Change in 6MWD, Baseline to 6-Month Visit Change from Baseline	17.6 meters Standard Deviation 87.6

SECONDARY outcome

Timeframe: Baseline and 1 Year

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

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=82 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in 6MWD, Baseline to 1-Year Visit Baseline Visit	278.1 meters Standard Deviation 84.5
Change in 6MWD, Baseline to 1-Year Visit 1-Year Visit	312.4 meters Standard Deviation 104.1
Change in 6MWD, Baseline to 1-Year Visit Change from Baseline	34.3 meters Standard Deviation 83.6

SECONDARY outcome

Timeframe: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

Population: The outcome is reported where data are available.

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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in NYHA Functional Classification Baseline · Class I	0 Participants
Change in NYHA Functional Classification 1 Year · Class IV	0 Participants
Change in NYHA Functional Classification 3 Years · Class I	27 Participants
Change in NYHA Functional Classification 3 Years · Class II	25 Participants
Change in NYHA Functional Classification 3 Years · Class IV	1 Participants
Change in NYHA Functional Classification Baseline · Class II	49 Participants
Change in NYHA Functional Classification Baseline · Class III	68 Participants
Change in NYHA Functional Classification Baseline · Class IV	6 Participants
Change in NYHA Functional Classification 6 Months · Class I	49 Participants
Change in NYHA Functional Classification 6 Months · Class II	52 Participants
Change in NYHA Functional Classification 6 Months · Class III	9 Participants
Change in NYHA Functional Classification 6 Months · Class IV	1 Participants
Change in NYHA Functional Classification 1 Year · Class I	44 Participants
Change in NYHA Functional Classification 1 Year · Class II	48 Participants
Change in NYHA Functional Classification 1 Year · Class III	10 Participants
Change in NYHA Functional Classification 2 Years · Class I	43 Participants
Change in NYHA Functional Classification 2 Years · Class II	33 Participants
Change in NYHA Functional Classification 2 Years · Class III	6 Participants
Change in NYHA Functional Classification 2 Years · Class IV	0 Participants
Change in NYHA Functional Classification 3 Years · Class III	9 Participants
Change in NYHA Functional Classification 4 Years · Class I	24 Participants
Change in NYHA Functional Classification 4 Years · Class II	22 Participants
Change in NYHA Functional Classification 4 Years · Class III	5 Participants
Change in NYHA Functional Classification 4 Years · Class IV	1 Participants

SECONDARY outcome

Timeframe: Baseline, 30 Days, 6 Months and 1 Year

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

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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
KCCQ OS Score by Study Visit Baseline Visit	54.6 score on a scale Standard Deviation 21.3
KCCQ OS Score by Study Visit 30-Day Visit	70.7 score on a scale Standard Deviation 17.8
KCCQ OS Score by Study Visit 6-Month Visit	71.7 score on a scale Standard Deviation 15.3
KCCQ OS Score by Study Visit 1-Year Visit	72.0 score on a scale Standard Deviation 16.7

SECONDARY outcome

Timeframe: Baseline and 30 Days

Population: 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 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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=120 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in KCCQ OS Score, Baseline to 30-Day Visit Baseline Visit	54.6 score on a scale Standard Deviation 21.7
Change in KCCQ OS Score, Baseline to 30-Day Visit 30-Day Visit	70.7 score on a scale Standard Deviation 17.8
Change in KCCQ OS Score, Baseline to 30-Day Visit Change from Baseline	16.0 score on a scale Standard Deviation 18.9

SECONDARY outcome

Timeframe: Baseline and 6 Months

Population: 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 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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=111 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in KCCQ OS Score, Baseline to 6-Month Visit Baseline Visit	56.2 score on a scale Standard Deviation 20.8
Change in KCCQ OS Score, Baseline to 6-Month Visit 6-Month Visit	71.7 score on a scale Standard Deviation 15.3
Change in KCCQ OS Score, Baseline to 6-Month Visit Change from Baseline	15.5 score on a scale Standard Deviation 18.5

SECONDARY outcome

Timeframe: Baseline and 1 Year

Population: Participants with KCCQ OS scores available for both the Baseline and 1-Year 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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=96 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in KCCQ OS Score, Baseline to 1-Year Visit Baseline Visit	56.1 score on a scale Standard Deviation 20.8
Change in KCCQ OS Score, Baseline to 1-Year Visit 1-Year Visit	72.0 score on a scale Standard Deviation 16.7
Change in KCCQ OS Score, Baseline to 1-Year Visit Change from Baseline	15.9 score on a scale Standard Deviation 17.4

SECONDARY outcome

Timeframe: Baseline, 30 Days, 6 Months and 1 Year

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

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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=123 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
EQ5D VAS Score by Study Visit Baseline Visit	62.8 score on a scale Standard Deviation 21.7
EQ5D VAS Score by Study Visit 30-Day Visit	74.3 score on a scale Standard Deviation 19.6
EQ5D VAS Score by Study Visit 6-Month Visit	75.1 score on a scale Standard Deviation 17.6
EQ5D VAS Score by Study Visit 1-Year Visit	73.4 score on a scale Standard Deviation 20.3

SECONDARY outcome

Timeframe: Baseline and 30 Days

Population: 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 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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=116 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in EQ5D VAS Score, Baseline to 30-Day Visit Baseline Visit	62.4 score on a scale Standard Deviation 22.1
Change in EQ5D VAS Score, Baseline to 30-Day Visit 30-Day Visit	74.2 score on a scale Standard Deviation 19.7
Change in EQ5D VAS Score, Baseline to 30-Day Visit Change from Baseline	11.8 score on a scale Standard Deviation 20.7

SECONDARY outcome

Timeframe: Baseline and 6 Months

Population: 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 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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=110 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in EQ5D VAS Score, Baseline to 6-Month Visit Baseline Visit	63.9 score on a scale Standard Deviation 21.4
Change in EQ5D VAS Score, Baseline to 6-Month Visit 6-Month Visit	75.3 score on a scale Standard Deviation 17.6
Change in EQ5D VAS Score, Baseline to 6-Month Visit Change from Baseline	11.5 score on a scale Standard Deviation 19.2

SECONDARY outcome

Timeframe: Baseline and 1 Year

Population: Participants with EQ5D VAS score values available for both the Baseline and 1-Year 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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=95 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in EQ5D VAS Score, Baseline to 1-Year Visit Baseline Visit	64.2 score on a scale Standard Deviation 21.4
Change in EQ5D VAS Score, Baseline to 1-Year Visit 1-Year Visit	73.4 score on a scale Standard Deviation 20.4
Change in EQ5D VAS Score, Baseline to 1-Year Visit Change from Baseline	9.2 score on a scale Standard Deviation 21.8

SECONDARY outcome

Timeframe: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

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

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=36 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
NT-proBNP by Study Visit Baseline Visit	4148.7 picograms per milliliter (pg/ml) Standard Deviation 6430.8
NT-proBNP by Study Visit 6-Month Visit	2835.0 picograms per milliliter (pg/ml) Standard Deviation 3817.8
NT-proBNP by Study Visit 1-Year Visit	2620.2 picograms per milliliter (pg/ml) Standard Deviation 3061.1
NT-proBNP by Study Visit 2-Year Visit	2038.2 picograms per milliliter (pg/ml) Standard Deviation 2636.6
NT-proBNP by Study Visit 3-Year Visit	2425.2 picograms per milliliter (pg/ml) Standard Deviation 2024.8
NT-proBNP by Study Visit 4-Year Visit	1837.6 picograms per milliliter (pg/ml) Standard Deviation 1718.0

SECONDARY outcome

Timeframe: Baseline and 6 Months

Population: 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 6-Month visit

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=25 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in NT-proBNP, Baseline to 6-Month Visit Baseline Visit	3594.7 picograms per milliliter (pg/ml) Standard Deviation 6145.9
Change in NT-proBNP, Baseline to 6-Month Visit 6-Month Visit	2695.5 picograms per milliliter (pg/ml) Standard Deviation 3934.3
Change in NT-proBNP, Baseline to 6-Month Visit Change from Baseline	-899.2 picograms per milliliter (pg/ml) Standard Deviation 6381.3

SECONDARY outcome

Timeframe: Baseline and 1 Year

Population: 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 1-Year visit

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=26 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in NT-proBNP, Baseline to 1-Year Visit Baseline Visit	3450.8 picograms per milliliter (pg/ml) Standard Deviation 6030.8
Change in NT-proBNP, Baseline to 1-Year Visit 1-Year Visit	2129.2 picograms per milliliter (pg/ml) Standard Deviation 1820.5
Change in NT-proBNP, Baseline to 1-Year Visit Change from Baseline	-1321.6 picograms per milliliter (pg/ml) Standard Deviation 5163.6

SECONDARY outcome

Timeframe: Baseline and 2 Years

Population: 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 2-Year visit

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=11 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in NT-proBNP, Baseline to 2-Year Visit Baseline Visit	2505.9 picograms per milliliter (pg/ml) Standard Deviation 2607.7
Change in NT-proBNP, Baseline to 2-Year Visit 2-Year Visit	1313.1 picograms per milliliter (pg/ml) Standard Deviation 841.0
Change in NT-proBNP, Baseline to 2-Year Visit Change from Baseline	-1192.8 picograms per milliliter (pg/ml) Standard Deviation 2186.3

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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 3-Year visit

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=10 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in NT-proBNP, Baseline to 3-Year Visit Baseline Visit	2802.4 picograms per milliliter (pg/ml) Standard Deviation 2801.1
Change in NT-proBNP, Baseline to 3-Year Visit 3-Year Visit	2513.6 picograms per milliliter (pg/ml) Standard Deviation 2083.5
Change in NT-proBNP, Baseline to 3-Year Visit Change from Baseline	-288.8 picograms per milliliter (pg/ml) Standard Deviation 2926.2

SECONDARY outcome

Timeframe: Baseline and 4 Years

Population: Participants with NT-proBNP measurements available for both the Baseline and 4-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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=8 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in NT-proBNP, Baseline to 4-Year Visit 4-Year Visit	1489.4 picograms per milliliter (pg/ml) Standard Deviation 991.4
Change in NT-proBNP, Baseline to 4-Year Visit Change from Baseline	-750.4 picograms per milliliter (pg/ml) Standard Deviation 2311.0
Change in NT-proBNP, Baseline to 4-Year Visit Baseline Visit	2239.8 picograms per milliliter (pg/ml) Standard Deviation 2977.4

SECONDARY outcome

Timeframe: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

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

Brain natriuretic peptide (BNP) level by study visit

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=87 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
BNP by Study Visit 3-Year Visit	500.0 picograms per milliliter (pg/ml) Standard Deviation 610.3
BNP by Study Visit 4-Year Visit	451.3 picograms per milliliter (pg/ml) Standard Deviation 456.6
BNP by Study Visit Baseline Visit	839.5 picograms per milliliter (pg/ml) Standard Deviation 904.4
BNP by Study Visit 6-Month Visit	588.0 picograms per milliliter (pg/ml) Standard Deviation 734.8
BNP by Study Visit 1-Year Visit	569.3 picograms per milliliter (pg/ml) Standard Deviation 923.8
BNP by Study Visit 2-Year Visit	472.4 picograms per milliliter (pg/ml) Standard Deviation 531.2

SECONDARY outcome

Timeframe: Baseline and 6 Months

Population: 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 6-Month visit

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=75 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in BNP, Baseline to 6-Month Visit Change from Baseline	-206.9 picograms per milliliter (pg/ml) Standard Deviation 607.5
Change in BNP, Baseline to 6-Month Visit Baseline Visit	813.5 picograms per milliliter (pg/ml) Standard Deviation 836.7
Change in BNP, Baseline to 6-Month Visit 6-Month Visit	606.6 picograms per milliliter (pg/ml) Standard Deviation 749.6

SECONDARY outcome

Timeframe: Baseline and 1 Year

Population: 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 1-Year visit

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=58 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change BNP, Baseline to 1-Year Visit Baseline Visit	746.7 picograms per milliliter (pg/ml) Standard Deviation 795.6
Change BNP, Baseline to 1-Year Visit 1-Year Visit	585.4 picograms per milliliter (pg/ml) Standard Deviation 944.8
Change BNP, Baseline to 1-Year Visit Change from Baseline	-161.3 picograms per milliliter (pg/ml) Standard Deviation 784.7

SECONDARY outcome

Timeframe: Baseline and 2 Years

Population: 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 2-Year visit

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=56 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in BNP, Baseline to 2-Year Visit Baseline Visit	720.6 picograms per milliliter (pg/ml) Standard Deviation 751.3
Change in BNP, Baseline to 2-Year Visit 2-Year Visit	470.8 picograms per milliliter (pg/ml) Standard Deviation 538.6
Change in BNP, Baseline to 2-Year Visit Change from Baseline	-249.8 picograms per milliliter (pg/ml) Standard Deviation 684.4

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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 3-Year visit

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=41 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in BNP, Baseline to 3-Year Visit Baseline Visit	744.2 picograms per milliliter (pg/ml) Standard Deviation 807.5
Change in BNP, Baseline to 3-Year Visit 3-Year Visit	510.4 picograms per milliliter (pg/ml) Standard Deviation 623.1
Change in BNP, Baseline to 3-Year Visit Change from Baseline	-233.9 picograms per milliliter (pg/ml) Standard Deviation 617.6

SECONDARY outcome

Timeframe: Baseline and 4 Years

Population: Participants with BNP measurements available for both the Baseline and 4-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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=32 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in BNP, Baseline to 4-Year Visit Baseline Visit	602.3 picograms per milliliter (pg/ml) Standard Deviation 588.1
Change in BNP, Baseline to 4-Year Visit 4-Year Visit	458.3 picograms per milliliter (pg/ml) Standard Deviation 468.0
Change in BNP, Baseline to 4-Year Visit Change from Baseline	-144.0 picograms per milliliter (pg/ml) Standard Deviation 572.6

SECONDARY outcome

Timeframe: 6 Month, 1 Year, 2 Years, 3 Years, 4 Years

Population: Participants with TR severity grades available for both the Baseline and follow-up visit 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.

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=109 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Tricuspid Regurgitation From Baseline 6-Month Visit · 3 Grade Increase	0 Participants
Change in Tricuspid Regurgitation From Baseline 6-Month Visit · 2 Grade Increase	1 Participants
Change in Tricuspid Regurgitation From Baseline 6-Month Visit · 1 Grade Increase	14 Participants
Change in Tricuspid Regurgitation From Baseline 6-Month Visit · No Change	58 Participants
Change in Tricuspid Regurgitation From Baseline 6-Month Visit · 1 Grade Decrease	35 Participants
Change in Tricuspid Regurgitation From Baseline 6-Month Visit · 2 Grade Decrease	1 Participants
Change in Tricuspid Regurgitation From Baseline 6-Month Visit · 3 Grade Decrease	0 Participants
Change in Tricuspid Regurgitation From Baseline 1-Year Visit · 3 Grade Increase	1 Participants
Change in Tricuspid Regurgitation From Baseline 1-Year Visit · 2 Grade Increase	1 Participants
Change in Tricuspid Regurgitation From Baseline 1-Year Visit · 1 Grade Increase	8 Participants
Change in Tricuspid Regurgitation From Baseline 1-Year Visit · No Change	49 Participants
Change in Tricuspid Regurgitation From Baseline 1-Year Visit · 1 Grade Decrease	30 Participants
Change in Tricuspid Regurgitation From Baseline 1-Year Visit · 2 Grade Decrease	2 Participants
Change in Tricuspid Regurgitation From Baseline 1-Year Visit · 3 Grade Decrease	0 Participants
Change in Tricuspid Regurgitation From Baseline 2-Year Visit · 3 Grade Increase	1 Participants
Change in Tricuspid Regurgitation From Baseline 2-Year Visit · 2 Grade Increase	1 Participants
Change in Tricuspid Regurgitation From Baseline 2-Year Visit · 1 Grade Increase	8 Participants
Change in Tricuspid Regurgitation From Baseline 2-Year Visit · No Change	40 Participants
Change in Tricuspid Regurgitation From Baseline 2-Year Visit · 1 Grade Decrease	18 Participants
Change in Tricuspid Regurgitation From Baseline 2-Year Visit · 2 Grade Decrease	2 Participants
Change in Tricuspid Regurgitation From Baseline 2-Year Visit · 3 Grade Decrease	0 Participants
Change in Tricuspid Regurgitation From Baseline 3-Year Visit · 3 Grade Increase	1 Participants
Change in Tricuspid Regurgitation From Baseline 3-Year Visit · 2 Grade Increase	4 Participants
Change in Tricuspid Regurgitation From Baseline 3-Year Visit · 1 Grade Increase	7 Participants
Change in Tricuspid Regurgitation From Baseline 3-Year Visit · No Change	34 Participants
Change in Tricuspid Regurgitation From Baseline 3-Year Visit · 1 Grade Decrease	12 Participants
Change in Tricuspid Regurgitation From Baseline 3-Year Visit · 2 Grade Decrease	1 Participants
Change in Tricuspid Regurgitation From Baseline 3-Year Visit · 3 Grade Decrease	0 Participants
Change in Tricuspid Regurgitation From Baseline 4-Year Visit · 3 Grade Increase	1 Participants
Change in Tricuspid Regurgitation From Baseline 4-Year Visit · 2 Grade Increase	3 Participants
Change in Tricuspid Regurgitation From Baseline 4-Year Visit · 1 Grade Increase	4 Participants
Change in Tricuspid Regurgitation From Baseline 4-Year Visit · No Change	27 Participants
Change in Tricuspid Regurgitation From Baseline 4-Year Visit · 1 Grade Decrease	10 Participants
Change in Tricuspid Regurgitation From Baseline 4-Year Visit · 2 Grade Decrease	1 Participants
Change in Tricuspid Regurgitation From Baseline 4-Year Visit · 3 Grade Decrease	0 Participants

SECONDARY outcome

Timeframe: Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

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

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=101 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Mitral EROA by Study Visit Baseline Visit	0.38 square centimeters Standard Deviation 0.15
Mitral EROA by Study Visit 30-Day Visit	0.17 square centimeters Standard Deviation 0.21
Mitral EROA by Study Visit 6-Month Visit	0.15 square centimeters Standard Deviation 0.06
Mitral EROA by Study Visit 1-Year Visit	0.18 square centimeters Standard Deviation 0.06
Mitral EROA by Study Visit 2-Year Visit	0.19 square centimeters Standard Deviation 0.03
Mitral EROA by Study Visit 3-Year Visit	0.24 square centimeters Standard Deviation 0.13
Mitral EROA by Study Visit 4-Year Visit	0.25 square centimeters Standard Deviation 0.10

SECONDARY outcome

Timeframe: Baseline and 30 Days

Population: 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 30-Day visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=24 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral EROA, Baseline to 30-Day Visit Baseline Visit	0.40 square centimeters Standard Deviation 0.17
Change in Mitral EROA, Baseline to 30-Day Visit 30-Day Visit	0.17 square centimeters Standard Deviation 0.21
Change in Mitral EROA, Baseline to 30-Day Visit Change from Baseline	-0.24 square centimeters Standard Deviation 0.22

SECONDARY outcome

Timeframe: Baseline and 6 Months

Population: 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 6-Month visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=15 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral EROA, Baseline to 6-Month Visit Baseline Visit	0.40 square centimeters Standard Deviation 0.15
Change in Mitral EROA, Baseline to 6-Month Visit 6-Month Visit	0.14 square centimeters Standard Deviation 0.06
Change in Mitral EROA, Baseline to 6-Month Visit Change from Baseline	-0.27 square centimeters Standard Deviation 0.15

SECONDARY outcome

Timeframe: Baseline and 1 Year

Population: 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 1-Year visit, , measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=9 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral EROA, Baseline to 1-Year Visit Baseline Visit	0.41 square centimeters Standard Deviation 0.21
Change in Mitral EROA, Baseline to 1-Year Visit 1-Year Visit	0.18 square centimeters Standard Deviation 0.06
Change in Mitral EROA, Baseline to 1-Year Visit Change from Baseline	-0.22 square centimeters Standard Deviation 0.20

SECONDARY outcome

Timeframe: Baseline and 2 Years

Population: 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 2-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=6 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral EROA, Baseline to 2-Year Visit Baseline Visit	0.35 square centimeters Standard Deviation 0.08
Change in Mitral EROA, Baseline to 2-Year Visit 2-Year Visit	0.19 square centimeters Standard Deviation 0.03
Change in Mitral EROA, Baseline to 2-Year Visit Change from Baseline	-0.16 square centimeters Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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 3-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=5 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral EROA, Baseline to 3-Year Visit Baseline Visit	0.36 square centimeters Standard Deviation 0.04
Change in Mitral EROA, Baseline to 3-Year Visit 3-Year Visit	0.25 square centimeters Standard Deviation 0.14
Change in Mitral EROA, Baseline to 3-Year Visit Change from Baseline	-0.11 square centimeters Standard Deviation 0.14

SECONDARY outcome

Timeframe: Baseline and 4 Years

Population: Participants with mitral EROA measurements available for both the Baseline and 4-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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=4 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral EROA, Baseline to 4-Year Visit Baseline Visit	0.44 square centimeters Standard Deviation 0.08
Change in Mitral EROA, Baseline to 4-Year Visit 4-Year Visit	0.28 square centimeters Standard Deviation 0.09
Change in Mitral EROA, Baseline to 4-Year Visit Change from Baseline	-0.16 square centimeters Standard Deviation 0.02

SECONDARY outcome

Timeframe: Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

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

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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=99 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Mitral Regurgitant Volume by Study Visit Baseline Visit	57.3 milliliters Standard Deviation 19.7
Mitral Regurgitant Volume by Study Visit 30-Day Visit	25.2 milliliters Standard Deviation 18.7
Mitral Regurgitant Volume by Study Visit 6-Month Visit	25.3 milliliters Standard Deviation 11.2
Mitral Regurgitant Volume by Study Visit 1-Year Visit	30.1 milliliters Standard Deviation 10.1
Mitral Regurgitant Volume by Study Visit 2-Year Visit	31.0 milliliters Standard Deviation 7.3
Mitral Regurgitant Volume by Study Visit 3-Year Visit	38.0 milliliters Standard Deviation 18.8
Mitral Regurgitant Volume by Study Visit 4-Year Visit	37.8 milliliters Standard Deviation 16.7

SECONDARY outcome

Timeframe: Baseline and 30 Days

Population: 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 30-Day visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=23 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit Baseline Visit	62.5 milliliters Standard Deviation 18.3
Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit 30-Day Visit	24.3 milliliters Standard Deviation 19.3
Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit Change from Baseline	-38.2 milliliters Standard Deviation 23.8

SECONDARY outcome

Timeframe: Baseline and 6 Months

Population: 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 6-Month visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=15 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit Baseline Visit	62.8 milliliters Standard Deviation 16.4
Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit 6-Month Visit	22.8 milliliters Standard Deviation 10.2
Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit Change from Baseline	-40.0 milliliters Standard Deviation 19.5

SECONDARY outcome

Timeframe: Baseline and 1 Year

Population: 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 1-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=9 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit Baseline Visit	61.5 milliliters Standard Deviation 16.0
Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit 1-Year Visit	30.3 milliliters Standard Deviation 10.7
Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit Change from Baseline	-31.2 milliliters Standard Deviation 17.6

SECONDARY outcome

Timeframe: Baseline and 2 Years

Population: 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 2-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=6 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit Baseline Visit	54.6 milliliters Standard Deviation 17.2
Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit 2-Year Visit	31.0 milliliters Standard Deviation 7.3
Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit Change from Baseline	-23.5 milliliters Standard Deviation 14.4

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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 3-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=5 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit Baseline Visit	59.9 milliliters Standard Deviation 13.5
Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit 3-Year Visit	40.1 milliliters Standard Deviation 20.2
Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit Change from Baseline	-19.8 milliliters Standard Deviation 17.1

SECONDARY outcome

Timeframe: Baseline and 4 Years

Population: Participants with mitral regurgitant volume measurements available for both the Baseline and 4-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

Outcome measures

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=4 Participants Mitral valve repair with PASCAL implanted via transcatheter procedure
Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit Baseline Visit	74.2 milliliters Standard Deviation 9.0
Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit 4-Year Visit	41.7 milliliters Standard Deviation 16.5
Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit Change from Baseline	-32.5 milliliters Standard Deviation 11.4

Adverse Events

Edwards PASCAL Transcatheter Mitral Valve Repair System

Serious events: 94 serious events

Other events: 33 other events

Deaths: 45 deaths

Serious adverse events

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 participants at risk Mitral valve repair with PASCAL implanted via transcatheter procedure
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	4.8% 6/124 • Number of events 8 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Gastrointestinal inflammation	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Pancreatitis acute	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Renal and urinary disorders Acute kidney injury	10.5% 13/124 • Number of events 16 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Acute left ventricular failure	2.4% 3/124 • Number of events 3 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Angina pectoris	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Angina unstable	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Aortic stenosis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Aortic valve stenosis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Atrial fibrillation	9.7% 12/124 • Number of events 13 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Bacteraemia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Reproductive system and breast disorders Benign prostatic hyperplasia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	1.6% 2/124 • Number of events 3 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Investigations Blood glucose increased	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Bradycardia	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations COVID-19	4.0% 5/124 • Number of events 5 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Cardiac ventricular thrombosis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Gallstone ileus	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Gastrointestinal haemorrhage	8.9% 11/124 • Number of events 14 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Haemorrhage	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Haemorrhagic stroke	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Osteomyelitis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Hepatobiliary disorders Portal vein thrombosis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Post stroke epilepsy	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Cardiac failure acute	7.3% 9/124 • Number of events 11 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
General disorders Chest pain	3.2% 4/124 • Number of events 4 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Compression fracture	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Coronary artery disease	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Metabolism and nutrition disorders Dehydration	2.4% 3/124 • Number of events 4 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Dementia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Product Issues Device dislocation	3.2% 4/124 • Number of events 4 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Foot fracture	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Hypertensive emergency	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Pharyngeal injury	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Investigations Anticoagulation drug level above therapeutic	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Cardiac arrest	5.6% 7/124 • Number of events 8 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Cardiorenal syndrome	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Cerebrovascular accident	2.4% 3/124 • Number of events 3 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Haemorrhage intracranial	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Surgical and medical procedures Heart transplant	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Lymphoedema	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Left ventricular failure	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Ankle fracture	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Arrhythmia	1.6% 2/124 • Number of events 3 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Atrial thrombosis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Atrioventricular block complete	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
General disorders Death	2.4% 3/124 • Number of events 3 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Metabolism and nutrition disorders Hyperkalaemia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Ischaemic stroke	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Joint dislocation	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Middle cerebral artery stroke	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Mitral valve incompetence	5.6% 7/124 • Number of events 8 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
General disorders Multiple organ dysfunction syndrome	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Myocardial infarction	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Pneumonia	6.5% 8/124 • Number of events 8 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Blood and lymphatic system disorders Anaemia	8.1% 10/124 • Number of events 10 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Cardiac failure congestive	6.5% 8/124 • Number of events 9 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Chronic left ventricular failure	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Colitis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Fall	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Gastroenteritis	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Haematochezia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Hypotension	6.5% 8/124 • Number of events 10 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Inguinal hernia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Mitral valve stenosis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Reproductive system and breast disorders Pelvic haematoma	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Peripheral ischaemia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Pharyngeal haematoma	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleomorphic liposarcoma	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Pneumonia aspiration	2.4% 3/124 • Number of events 3 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Poor peripheral circulation	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Anaemia postoperative	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
General disorders Asthenia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Fractured sacrum	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Peripheral artery occlusion	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Cardio-respiratory arrest	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Arteriosclerosis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Arthritis infective	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Atrial flutter	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Cardiac failure chronic	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Haematoma	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Investigations International normalised ratio increased	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Melaena	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Normal pressure hydrocephalus	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations COVID-19 pneumonia	2.4% 3/124 • Number of events 3 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Cardiogenic shock	3.2% 4/124 • Number of events 4 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Gastritis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Hip fracture	2.4% 3/124 • Number of events 3 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Blood and lymphatic system disorders Leukocytosis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Nosocomial infection	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Cardiomyopathy	2.4% 3/124 • Number of events 3 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Abscess limb	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
General disorders Device related thrombosis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Psychiatric disorders Mental status changes	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 2/124 • Number of events 5 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Arrhythmic storm	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Acute myocardial infarction	3.2% 4/124 • Number of events 4 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Cardiac failure	14.5% 18/124 • Number of events 43 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Diverticulum intestinal	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Ischaemic cerebral infarction	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Metabolic encephalopathy	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
General disorders Device embolisation	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Dysphagia	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Femoral neck fracture	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Renal and urinary disorders Haematuria	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Metabolism and nutrition disorders Hypervolaemia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Metabolism and nutrition disorders Hypoglycaemia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Metabolism and nutrition disorders Lactic acidosis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
General disorders Non-cardiac chest pain	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Rib fracture	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Seizure	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer recurrent	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Respiratory syncytial virus infection	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Sepsis	4.8% 6/124 • Number of events 6 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Reproductive system and breast disorders Prostatitis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
General disorders Pyrexia	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Renal and urinary disorders Renal failure	3.2% 4/124 • Number of events 4 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Respiratory tract infection	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.8% 6/124 • Number of events 6 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Blood and lymphatic system disorders Thrombocytopenia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Tachycardia	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Tricuspid valve incompetence	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Ventricular extrasystoles	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Ventricular fibrillation	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Ventricular tachycardia	1.6% 2/124 • Number of events 4 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Gastrointestinal disorders Upper gastrointestinal haemorrhage	2.4% 3/124 • Number of events 5 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Septic shock	2.4% 3/124 • Number of events 3 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Urinary tract infection	4.8% 6/124 • Number of events 7 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Viral infection	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Spinal compression fracture	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Tongue injury	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Traumatic lung injury	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Urethral injury	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Vascular access site haematoma	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Injury, poisoning and procedural complications Vascular access site haemorrhage	1.6% 2/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Investigations Transplant evaluation	0.81% 1/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Syncope	0.81% 1/124 • Number of events 2 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Nervous system disorders Transient ischaemic attack	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Renal and urinary disorders Urinary retention	3.2% 4/124 • Number of events 4 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Shock	0.81% 1/124 • Number of events 1 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)

Other adverse events

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n=124 participants at risk Mitral valve repair with PASCAL implanted via transcatheter procedure
Cardiac disorders Atrial fibrillation	8.9% 11/124 • Number of events 13 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Cardiac disorders Cardiac failure	8.1% 10/124 • Number of events 10 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Infections and infestations Urinary tract infection	7.3% 9/124 • Number of events 11 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Renal and urinary disorders Acute kidney injury	5.6% 7/124 • Number of events 7 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)
Vascular disorders Hypotension	5.6% 7/124 • Number of events 8 • 4 year follow up All adverse events, including all-cause mortality, are reported through the exact 4-year day (day 1460)

Additional Information

Ted Feldman

Edwards Lifesciences

Phone: 949-250-2500

Email: Feldman_Info@edwards.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place