Mitral Valve Regurgitation
Conditions
Brief summary
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
Detailed description
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes study.
Interventions
DEVICEMitral Valve Repair
Minimal Invasive Transcatheter Mitral Valve Repair
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed and dated IRB/ethics committee approved study consent form prior to study related procedures * Eighteen (18) years of age or older * New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy * Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation * Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE). * The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant. * Mitral valve area (MVA) ≥ 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable.
Exclusion criteria
* Patient in whom a TEE is contraindicated or screening TEE is unsuccessful * Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation. * Mitral valve area (MVA) \< 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable) * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation * Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction * Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator * Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment * Patient is under guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | Exit from the cardiac catheterization laboratory | 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. |
| Number of Participants With Procedural Success | through discharge | 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. |
| Clinical Success | 30 days | 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. |
| Number of Participants With Major Adverse Events (MAE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reintervention Rates for Mitral Regurgitation | 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. |
| LVEDV by Study Visit | Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years | Left ventricular end diastolic volume (LVEDV) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging |
| Change in LVEDV, Baseline to 6-Month Visit | Baseline and 6 Months | 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 |
| Change in LVEDV, Baseline to 1-Year Visit | Baseline and 1 Year | 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 |
| Change in LVEDV, Baseline to 2-Year Visit | Baseline and 2 Years | 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 |
| Change in LVEDV, Baseline to 3-Year Visit | Baseline and 3 Years | 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 |
| Change in LVEDV, Baseline to 4-Year Visit | Baseline and 4 Years | 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 |
| LVESV by Study Visit | Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years | Left ventricular end systolic volume (LVESV) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging |
| Change in LVESV, Baseline to 6-Month Visit | Baseline and 6 Months | 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 |
| Change in LVESV, Baseline to 1-Year Visit | Baseline and 1 Year | 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 |
| Change in LVESV, Baseline to 2-Year Visit | Baseline and 2 Years | 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 |
| Change in LVESV, Baseline to 3-Year Visit | Baseline and 3 Years | 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 |
| Change in LVESV, Baseline to 4-Year Visit | Baseline and 4 Years | 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 |
| PASP by Study Visit | Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years | Pulmonary artery systolic pressure (PASP) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging |
| Change in PASP, Baseline to 6-Month Visit | Baseline and 6 Months | 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 |
| Change in PASP, Baseline to 1-Year Visit | Baseline and 1 Year | 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 |
| Change in PASP, Baseline to 2-Year Visit | Baseline and 2 Years | 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 |
| Change in PASP, Baseline to 3-Year Visit | Baseline and 3 Years | 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 |
| Change in PASP, Baseline to 4-Year Visit | Baseline and 4 Years | 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 |
| 6MWD by Study Visit | Baseline, 6 Months and 1 Year | Six-minute walk distance (6MWD) by study visit |
| Change in 6MWD, Baseline to 6-Month Visit | Baseline and 6 Months | Change in 6-minute walk distance (6MWD) from the Baseline to the 6-Month visit |
| Change in 6MWD, Baseline to 1-Year Visit | Baseline and 1 Year | Change 6-minute walk distance (6MWD) from the Baseline to the 1-Year visit |
| Change in NYHA Functional Classification | Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years | 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. |
| KCCQ OS Score by Study Visit | Baseline, 30 Days, 6 Months and 1 Year | 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. |
| Change in KCCQ OS Score, Baseline to 30-Day Visit | Baseline and 30 Days | 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. |
| Change in KCCQ OS Score, Baseline to 6-Month Visit | Baseline and 6 Months | 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. |
| Change in KCCQ OS Score, Baseline to 1-Year Visit | Baseline and 1 Year | 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. |
| EQ5D VAS Score by Study Visit | Baseline, 30 Days, 6 Months and 1 Year | 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. |
| Change in EQ5D VAS Score, Baseline to 30-Day Visit | Baseline and 30 Days | 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. |
| Change in EQ5D VAS Score, Baseline to 6-Month Visit | Baseline and 6 Months | 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. |
| Change in EQ5D VAS Score, Baseline to 1-Year Visit | Baseline and 1 Year | 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. |
| NT-proBNP by Study Visit | Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years | N-terminal pro-B-type natriuretic peptide (NT-proBNP) level by study visit. |
| Change in NT-proBNP, Baseline to 6-Month Visit | Baseline and 6 Months | Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 6-Month visit |
| Change in NT-proBNP, Baseline to 1-Year Visit | Baseline and 1 Year | Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 1-Year visit |
| Change in NT-proBNP, Baseline to 2-Year Visit | Baseline and 2 Years | Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 2-Year visit |
| Change in NT-proBNP, Baseline to 3-Year Visit | Baseline and 3 Years | Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 3-Year visit |
| Change in NT-proBNP, Baseline to 4-Year Visit | Baseline and 4 Years | Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 4-Year visit |
| BNP by Study Visit | Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years | Brain natriuretic peptide (BNP) level by study visit |
| Change in BNP, Baseline to 6-Month Visit | Baseline and 6 Months | Change in brain natriuretic peptide (BNP) level from the Baseline to the 6-Month visit |
| Change BNP, Baseline to 1-Year Visit | Baseline and 1 Year | Change in brain natriuretic peptide (BNP) level from the Baseline to the 1-Year visit |
| Change in BNP, Baseline to 2-Year Visit | Baseline and 2 Years | Change in brain natriuretic peptide (BNP) level from the Baseline to the 2-Year visit |
| Change in BNP, Baseline to 3-Year Visit | Baseline and 3 Years | Change in brain natriuretic peptide (BNP) level from the Baseline to the 3-Year visit |
| Change in BNP, Baseline to 4-Year Visit | Baseline and 4 Years | Change in brain natriuretic peptide (BNP) level from the Baseline to the 4-Year visit |
| Change in Tricuspid Regurgitation From Baseline | 6 Month, 1 Year, 2 Years, 3 Years, 4 Years | 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. |
| Mitral EROA by Study Visit | Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years | 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 |
| Change in Mitral EROA, Baseline to 30-Day Visit | Baseline and 30 Days | 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 |
| Change in Mitral EROA, Baseline to 6-Month Visit | Baseline and 6 Months | 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 |
| Change in Mitral EROA, Baseline to 1-Year Visit | Baseline and 1 Year | 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 |
| Change in Mitral EROA, Baseline to 2-Year Visit | Baseline and 2 Years | 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 |
| Change in Mitral EROA, Baseline to 3-Year Visit | Baseline and 3 Years | 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 |
| Change in Mitral EROA, Baseline to 4-Year Visit | Baseline and 4 Years | 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 |
| Mitral Regurgitant Volume by Study Visit | Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years | 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 |
| Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit | Baseline and 30 Days | 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 |
| Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit | Baseline and 6 Months | 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 |
| Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit | Baseline and 1 Year | 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 |
| Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit | Baseline and 2 Years | 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 |
| Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit | Baseline and 3 Years | 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 |
| 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, 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. |
| Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit | Baseline and 4 Years | 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 |
| Mitral Regurgitation Reduction | Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years | 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. |
| All-cause Mortality | 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. |
| Recurrent Heart Failure Hospitalization | 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. |
Countries
Australia, Canada, Germany, Greece, Italy, Switzerland, United States
Contacts
PRINCIPAL_INVESTIGATORGideon Cohen, MD
Sunnybrook Hospital
PRINCIPAL_INVESTIGATORUlrich Schafer, MD
BundeswehrZentralkrankenhaus Koblenz
PRINCIPAL_INVESTIGATORMolly Szerlip, MD
The Heart Hospital Baylor
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System Mitral valve repair with PASCAL implanted via transcatheter procedure | 124 |
| Total | 124 |
Baseline characteristics
| Characteristic | Edwards PASCAL Transcatheter Mitral Valve Repair System |
|---|---|
| Age, Continuous | 74.9 years STANDARD_DEVIATION 11.2 |
| Body Mass Index | 26.2 kilogram/meter square STANDARD_DEVIATION 4.9 |
| EuroSCORE II | 5.8 Units on a scale STANDARD_DEVIATION 5.4 |
| Height | 66.7 inches STANDARD_DEVIATION 4.1 |
| NYHA Class Class I | 0 Participants |
| NYHA Class Class II | 49 Participants |
| NYHA Class Class III | 68 Participants |
| NYHA Class Class IV | 6 Participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 69 Participants |
| STS Mortality Score | 4.6 Units on a scale STANDARD_DEVIATION 3.3 |
| Tobacco Use Current daily smoker | 4 Participants |
| Tobacco Use Former daily smoker | 63 Participants |
| Tobacco Use Never | 57 Participants |
| Weight | 165.4 pounds STANDARD_DEVIATION 34 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 45 / 124 |
| other Total, other adverse events | 33 / 124 |
| serious Total, serious adverse events | 94 / 124 |
Outcome results
Primary
Clinical Success
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.
Time frame: 30 days
Population: Participants with clinical success data available after collection of all study data for the 30-Day visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Clinical Success | 105 Participants |
Primary
Device Success
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.
Time frame: Exit from the cardiac catheterization laboratory
Population: Per device analysis
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Device Success | 175 Device |
Primary
Number of Participants With Major Adverse Events (MAE)
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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Number of Participants With Major Adverse Events (MAE) | 10 Participants |
Primary
Number of Participants With Procedural Success
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.
Time frame: through discharge
Population: Participants with procedural success data available after collection of all study data for the Discharge visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Number of Participants With Procedural Success | 115 Participants |
Secondary
6MWD by Study Visit
Six-minute walk distance (6MWD) by study visit
Time frame: Baseline, 6 Months and 1 Year
Population: Participants with a 6MWD measurement available after collection of all study data for the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | 6MWD by Study Visit | Baseline Visit | 265.4 meters | Standard Deviation 86.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | 6MWD by Study Visit | 6-Month Visit | 290.8 meters | Standard Deviation 103.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | 6MWD by Study Visit | 1-Year Visit | 312.4 meters | Standard Deviation 104.1 |
Secondary
All-cause Mortality
All-cause mortality at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative deaths at each time point.
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 Years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | All-cause Mortality | 30 days | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | All-cause Mortality | 6 months | 4 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | All-cause Mortality | 1 year | 10 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | All-cause Mortality | 2 years | 23 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | All-cause Mortality | 3 years | 31 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | All-cause Mortality | 4 years | 45 Participants |
Secondary
BNP by Study Visit
Brain natriuretic peptide (BNP) level by study visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | BNP by Study Visit | Baseline Visit | 839.5 picograms per milliliter (pg/ml) | Standard Deviation 904.4 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | BNP by Study Visit | 6-Month Visit | 588.0 picograms per milliliter (pg/ml) | Standard Deviation 734.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | BNP by Study Visit | 1-Year Visit | 569.3 picograms per milliliter (pg/ml) | Standard Deviation 923.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | BNP by Study Visit | 2-Year Visit | 472.4 picograms per milliliter (pg/ml) | Standard Deviation 531.2 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | BNP by Study Visit | 3-Year Visit | 500.0 picograms per milliliter (pg/ml) | Standard Deviation 610.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | BNP by Study Visit | 4-Year Visit | 451.3 picograms per milliliter (pg/ml) | Standard Deviation 456.6 |
Secondary
Change BNP, Baseline to 1-Year Visit
Change in brain natriuretic peptide (BNP) level from the Baseline to the 1-Year visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change BNP, Baseline to 1-Year Visit | Baseline Visit | 746.7 picograms per milliliter (pg/ml) | Standard Deviation 795.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change BNP, Baseline to 1-Year Visit | 1-Year Visit | 585.4 picograms per milliliter (pg/ml) | Standard Deviation 944.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change BNP, Baseline to 1-Year Visit | Change from Baseline | -161.3 picograms per milliliter (pg/ml) | Standard Deviation 784.7 |
Secondary
Change in 6MWD, Baseline to 1-Year Visit
Change 6-minute walk distance (6MWD) from the Baseline to the 1-Year visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in 6MWD, Baseline to 1-Year Visit | Baseline Visit | 278.1 meters | Standard Deviation 84.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in 6MWD, Baseline to 1-Year Visit | 1-Year Visit | 312.4 meters | Standard Deviation 104.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in 6MWD, Baseline to 1-Year Visit | Change from Baseline | 34.3 meters | Standard Deviation 83.6 |
Secondary
Change in 6MWD, Baseline to 6-Month Visit
Change in 6-minute walk distance (6MWD) from the Baseline to the 6-Month visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in 6MWD, Baseline to 6-Month Visit | Baseline Visit | 273.2 meters | Standard Deviation 87.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in 6MWD, Baseline to 6-Month Visit | 6-Month Visit | 290.8 meters | Standard Deviation 103.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in 6MWD, Baseline to 6-Month Visit | Change from Baseline | 17.6 meters | Standard Deviation 87.6 |
Secondary
Change in BNP, Baseline to 2-Year Visit
Change in brain natriuretic peptide (BNP) level from the Baseline to the 2-Year visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 2-Year Visit | Baseline Visit | 720.6 picograms per milliliter (pg/ml) | Standard Deviation 751.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 2-Year Visit | 2-Year Visit | 470.8 picograms per milliliter (pg/ml) | Standard Deviation 538.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 2-Year Visit | Change from Baseline | -249.8 picograms per milliliter (pg/ml) | Standard Deviation 684.4 |
Secondary
Change in BNP, Baseline to 3-Year Visit
Change in brain natriuretic peptide (BNP) level from the Baseline to the 3-Year visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 3-Year Visit | Baseline Visit | 744.2 picograms per milliliter (pg/ml) | Standard Deviation 807.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 3-Year Visit | 3-Year Visit | 510.4 picograms per milliliter (pg/ml) | Standard Deviation 623.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 3-Year Visit | Change from Baseline | -233.9 picograms per milliliter (pg/ml) | Standard Deviation 617.6 |
Secondary
Change in BNP, Baseline to 4-Year Visit
Change in brain natriuretic peptide (BNP) level from the Baseline to the 4-Year visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 4-Year Visit | Baseline Visit | 602.3 picograms per milliliter (pg/ml) | Standard Deviation 588.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 4-Year Visit | 4-Year Visit | 458.3 picograms per milliliter (pg/ml) | Standard Deviation 468 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 4-Year Visit | Change from Baseline | -144.0 picograms per milliliter (pg/ml) | Standard Deviation 572.6 |
Secondary
Change in BNP, Baseline to 6-Month Visit
Change in brain natriuretic peptide (BNP) level from the Baseline to the 6-Month visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 6-Month Visit | Baseline Visit | 813.5 picograms per milliliter (pg/ml) | Standard Deviation 836.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 6-Month Visit | 6-Month Visit | 606.6 picograms per milliliter (pg/ml) | Standard Deviation 749.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in BNP, Baseline to 6-Month Visit | Change from Baseline | -206.9 picograms per milliliter (pg/ml) | Standard Deviation 607.5 |
Secondary
Change in EQ5D VAS Score, Baseline to 1-Year Visit
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in EQ5D VAS Score, Baseline to 1-Year Visit | Baseline Visit | 64.2 score on a scale | Standard Deviation 21.4 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in EQ5D VAS Score, Baseline to 1-Year Visit | 1-Year Visit | 73.4 score on a scale | Standard Deviation 20.4 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in EQ5D VAS Score, Baseline to 1-Year Visit | Change from Baseline | 9.2 score on a scale | Standard Deviation 21.8 |
Secondary
Change in EQ5D VAS Score, Baseline to 30-Day Visit
Change in EQ5D visual analogue scale (VAS) score from the Baseline to the 30-Day visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in EQ5D VAS Score, Baseline to 30-Day Visit | Baseline Visit | 62.4 score on a scale | Standard Deviation 22.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in EQ5D VAS Score, Baseline to 30-Day Visit | 30-Day Visit | 74.2 score on a scale | Standard Deviation 19.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in EQ5D VAS Score, Baseline to 30-Day Visit | Change from Baseline | 11.8 score on a scale | Standard Deviation 20.7 |
Secondary
Change in EQ5D VAS Score, Baseline to 6-Month Visit
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in EQ5D VAS Score, Baseline to 6-Month Visit | Baseline Visit | 63.9 score on a scale | Standard Deviation 21.4 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in EQ5D VAS Score, Baseline to 6-Month Visit | 6-Month Visit | 75.3 score on a scale | Standard Deviation 17.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in EQ5D VAS Score, Baseline to 6-Month Visit | Change from Baseline | 11.5 score on a scale | Standard Deviation 19.2 |
Secondary
Change in KCCQ OS Score, Baseline to 1-Year Visit
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in KCCQ OS Score, Baseline to 1-Year Visit | Baseline Visit | 56.1 score on a scale | Standard Deviation 20.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in KCCQ OS Score, Baseline to 1-Year Visit | 1-Year Visit | 72.0 score on a scale | Standard Deviation 16.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in KCCQ OS Score, Baseline to 1-Year Visit | Change from Baseline | 15.9 score on a scale | Standard Deviation 17.4 |
Secondary
Change in KCCQ OS Score, Baseline to 30-Day Visit
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ OS) Score from the Baseline to the 30-Day visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in KCCQ OS Score, Baseline to 30-Day Visit | Baseline Visit | 54.6 score on a scale | Standard Deviation 21.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in KCCQ OS Score, Baseline to 30-Day Visit | 30-Day Visit | 70.7 score on a scale | Standard Deviation 17.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in KCCQ OS Score, Baseline to 30-Day Visit | Change from Baseline | 16.0 score on a scale | Standard Deviation 18.9 |
Secondary
Change in KCCQ OS Score, Baseline to 6-Month Visit
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in KCCQ OS Score, Baseline to 6-Month Visit | Baseline Visit | 56.2 score on a scale | Standard Deviation 20.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in KCCQ OS Score, Baseline to 6-Month Visit | 6-Month Visit | 71.7 score on a scale | Standard Deviation 15.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in KCCQ OS Score, Baseline to 6-Month Visit | Change from Baseline | 15.5 score on a scale | Standard Deviation 18.5 |
Secondary
Change in LVEDV, Baseline to 1-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 1-Year Visit | Baseline Visit | 178.0 milliliters | Standard Deviation 61.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 1-Year Visit | 1-Year Visit | 153.3 milliliters | Standard Deviation 54.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 1-Year Visit | Change from Baseline | -24.6 milliliters | Standard Deviation 34.8 |
Secondary
Change in LVEDV, Baseline to 2-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 2-Year Visit | Baseline Visit | 182.1 milliliters | Standard Deviation 64 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 2-Year Visit | 2-Year Visit | 153.0 milliliters | Standard Deviation 57.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 2-Year Visit | Change from Baseline | -29.1 milliliters | Standard Deviation 38.3 |
Secondary
Change in LVEDV, Baseline to 3-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 3-Year Visit | Baseline Visit | 187.6 milliliters | Standard Deviation 66 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 3-Year Visit | 3-Year Visit | 161.5 milliliters | Standard Deviation 64.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 3-Year Visit | Change from Baseline | -26.1 milliliters | Standard Deviation 38.2 |
Secondary
Change in LVEDV, Baseline to 4-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 4-Year Visit | 4-Year Visit | 147.6 milliliters | Standard Deviation 64.9 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 4-Year Visit | Baseline Visit | 174.2 milliliters | Standard Deviation 64.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 4-Year Visit | Change from Baseline | -26.6 milliliters | Standard Deviation 33.6 |
Secondary
Change in LVEDV, Baseline to 6-Month Visit
Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 6-Month Visit | Baseline Visit | 187.3 milliliters | Standard Deviation 60.9 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 6-Month Visit | 6-Month Visit | 169.9 milliliters | Standard Deviation 61.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVEDV, Baseline to 6-Month Visit | Change from Baseline | -17.4 milliliters | Standard Deviation 30.5 |
Secondary
Change in LVESV, Baseline to 1-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 1-Year Visit | Baseline Visit | 104.6 milliliters | Standard Deviation 54.9 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 1-Year Visit | 1-Year Visit | 90.8 milliliters | Standard Deviation 48.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 1-Year Visit | Change from Baseline | -13.7 milliliters | Standard Deviation 27 |
Secondary
Change in LVESV, Baseline to 2-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 2-Year Visit | Baseline Visit | 109.6 milliliters | Standard Deviation 59.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 2-Year Visit | 2-Year Visit | 91.6 milliliters | Standard Deviation 51.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 2-Year Visit | Change from Baseline | -18.0 milliliters | Standard Deviation 30 |
Secondary
Change in LVESV, Baseline to 3-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 3-Year Visit | Baseline Visit | 114.5 milliliters | Standard Deviation 60.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 3-Year Visit | 6-Month Visit | 100.2 milliliters | Standard Deviation 57.4 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 3-Year Visit | Change from Baseline | -14.4 milliliters | Standard Deviation 28.9 |
Secondary
Change in LVESV, Baseline to 4-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 4-Year Visit | Baseline Visit | 101.7 milliliters | Standard Deviation 59.2 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 4-Year Visit | 4-Year Visit | 88.1 milliliters | Standard Deviation 56.9 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 4-Year Visit | Change from Baseline | -13.6 milliliters | Standard Deviation 30.4 |
Secondary
Change in LVESV, Baseline to 6-Month Visit
Change in left ventricular end systolic volume (LVESV) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 6-Month Visit | Change from Baseline | -9.3 milliliters | Standard Deviation 22.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 6-Month Visit | Baseline Visit | 112.6 milliliters | Standard Deviation 56.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in LVESV, Baseline to 6-Month Visit | 6-Month Visit | 103.2 milliliters | Standard Deviation 54.2 |
Secondary
Change in Mitral EROA, Baseline to 1-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 1-Year Visit | 1-Year Visit | 0.18 square centimeters | Standard Deviation 0.06 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 1-Year Visit | Baseline Visit | 0.41 square centimeters | Standard Deviation 0.21 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 1-Year Visit | Change from Baseline | -0.22 square centimeters | Standard Deviation 0.2 |
Secondary
Change in Mitral EROA, Baseline to 2-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 2-Year Visit | Baseline Visit | 0.35 square centimeters | Standard Deviation 0.08 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 2-Year Visit | 2-Year Visit | 0.19 square centimeters | Standard Deviation 0.03 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 2-Year Visit | Change from Baseline | -0.16 square centimeters | Standard Deviation 0.06 |
Secondary
Change in Mitral EROA, Baseline to 30-Day Visit
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 30-Day visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 30-Day Visit | Baseline Visit | 0.40 square centimeters | Standard Deviation 0.17 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 30-Day Visit | 30-Day Visit | 0.17 square centimeters | Standard Deviation 0.21 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 30-Day Visit | Change from Baseline | -0.24 square centimeters | Standard Deviation 0.22 |
Secondary
Change in Mitral EROA, Baseline to 3-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 3-Year Visit | Baseline Visit | 0.36 square centimeters | Standard Deviation 0.04 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 3-Year Visit | 3-Year Visit | 0.25 square centimeters | Standard Deviation 0.14 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 3-Year Visit | Change from Baseline | -0.11 square centimeters | Standard Deviation 0.14 |
Secondary
Change in Mitral EROA, Baseline to 4-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 4-Year Visit | Baseline Visit | 0.44 square centimeters | Standard Deviation 0.08 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 4-Year Visit | 4-Year Visit | 0.28 square centimeters | Standard Deviation 0.09 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 4-Year Visit | Change from Baseline | -0.16 square centimeters | Standard Deviation 0.02 |
Secondary
Change in Mitral EROA, Baseline to 6-Month Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 6-Month Visit | Baseline Visit | 0.40 square centimeters | Standard Deviation 0.15 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 6-Month Visit | 6-Month Visit | 0.14 square centimeters | Standard Deviation 0.06 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral EROA, Baseline to 6-Month Visit | Change from Baseline | -0.27 square centimeters | Standard Deviation 0.15 |
Secondary
Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit | Baseline Visit | 61.5 milliliters | Standard Deviation 16 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit | 1-Year Visit | 30.3 milliliters | Standard Deviation 10.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit | Change from Baseline | -31.2 milliliters | Standard Deviation 17.6 |
Secondary
Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit | Baseline Visit | 54.6 milliliters | Standard Deviation 17.2 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit | 2-Year Visit | 31.0 milliliters | Standard Deviation 7.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit | Change from Baseline | -23.5 milliliters | Standard Deviation 14.4 |
Secondary
Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit
Change in mitral regurgitant volume from the Baseline to the 30-Day visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit | Change from Baseline | -38.2 milliliters | Standard Deviation 23.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit | Baseline Visit | 62.5 milliliters | Standard Deviation 18.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit | 30-Day Visit | 24.3 milliliters | Standard Deviation 19.3 |
Secondary
Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit | Baseline Visit | 59.9 milliliters | Standard Deviation 13.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit | 3-Year Visit | 40.1 milliliters | Standard Deviation 20.2 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit | Change from Baseline | -19.8 milliliters | Standard Deviation 17.1 |
Secondary
Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit | Baseline Visit | 74.2 milliliters | Standard Deviation 9 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit | 4-Year Visit | 41.7 milliliters | Standard Deviation 16.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit | Change from Baseline | -32.5 milliliters | Standard Deviation 11.4 |
Secondary
Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit | Baseline Visit | 62.8 milliliters | Standard Deviation 16.4 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit | 6-Month Visit | 22.8 milliliters | Standard Deviation 10.2 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit | Change from Baseline | -40.0 milliliters | Standard Deviation 19.5 |
Secondary
Change in NT-proBNP, Baseline to 1-Year Visit
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 1-Year visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 1-Year Visit | Baseline Visit | 3450.8 picograms per milliliter (pg/ml) | Standard Deviation 6030.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 1-Year Visit | 1-Year Visit | 2129.2 picograms per milliliter (pg/ml) | Standard Deviation 1820.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 1-Year Visit | Change from Baseline | -1321.6 picograms per milliliter (pg/ml) | Standard Deviation 5163.6 |
Secondary
Change in NT-proBNP, Baseline to 2-Year Visit
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 2-Year visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 2-Year Visit | Baseline Visit | 2505.9 picograms per milliliter (pg/ml) | Standard Deviation 2607.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 2-Year Visit | 2-Year Visit | 1313.1 picograms per milliliter (pg/ml) | Standard Deviation 841 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 2-Year Visit | Change from Baseline | -1192.8 picograms per milliliter (pg/ml) | Standard Deviation 2186.3 |
Secondary
Change in NT-proBNP, Baseline to 3-Year Visit
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 3-Year visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 3-Year Visit | Baseline Visit | 2802.4 picograms per milliliter (pg/ml) | Standard Deviation 2801.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 3-Year Visit | 3-Year Visit | 2513.6 picograms per milliliter (pg/ml) | Standard Deviation 2083.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 3-Year Visit | Change from Baseline | -288.8 picograms per milliliter (pg/ml) | Standard Deviation 2926.2 |
Secondary
Change in NT-proBNP, Baseline to 4-Year Visit
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 4-Year visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 4-Year Visit | Baseline Visit | 2239.8 picograms per milliliter (pg/ml) | Standard Deviation 2977.4 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 4-Year Visit | 4-Year Visit | 1489.4 picograms per milliliter (pg/ml) | Standard Deviation 991.4 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 4-Year Visit | Change from Baseline | -750.4 picograms per milliliter (pg/ml) | Standard Deviation 2311 |
Secondary
Change in NT-proBNP, Baseline to 6-Month Visit
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 6-Month visit
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 6-Month Visit | Baseline Visit | 3594.7 picograms per milliliter (pg/ml) | Standard Deviation 6145.9 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 6-Month Visit | 6-Month Visit | 2695.5 picograms per milliliter (pg/ml) | Standard Deviation 3934.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NT-proBNP, Baseline to 6-Month Visit | Change from Baseline | -899.2 picograms per milliliter (pg/ml) | Standard Deviation 6381.3 |
Secondary
Change in NYHA Functional Classification
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.
Time frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Population: The outcome is reported where data are available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | Baseline | Class I | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | Baseline | Class II | 49 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | Baseline | Class III | 68 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | Baseline | Class IV | 6 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 6 Months | Class I | 49 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 6 Months | Class II | 52 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 6 Months | Class III | 9 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 6 Months | Class IV | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 1 Year | Class I | 44 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 1 Year | Class II | 48 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 1 Year | Class III | 10 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 1 Year | Class IV | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 2 Years | Class I | 43 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 2 Years | Class II | 33 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 2 Years | Class III | 6 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 2 Years | Class IV | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 3 Years | Class I | 27 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 3 Years | Class II | 25 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 3 Years | Class III | 9 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 3 Years | Class IV | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 4 Years | Class I | 24 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 4 Years | Class II | 22 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 4 Years | Class III | 5 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in NYHA Functional Classification | 4 Years | Class IV | 1 Participants |
Secondary
Change in PASP, Baseline to 1-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 1-Year Visit | Baseline Visit | 46.4 millimeters of mercury (mmHg) | Standard Deviation 11.9 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 1-Year Visit | 1-Year Visit | 40.2 millimeters of mercury (mmHg) | Standard Deviation 11.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 1-Year Visit | Change from Baseline | -6.2 millimeters of mercury (mmHg) | Standard Deviation 12.9 |
Secondary
Change in PASP, Baseline to 2-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 2-Year Visit | Baseline Visit | 45.0 millimeters of mercury (mmHg) | Standard Deviation 12.2 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 2-Year Visit | 2-Year Visit | 38.0 millimeters of mercury (mmHg) | Standard Deviation 11.9 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 2-Year Visit | Change from Baseline | -6.9 millimeters of mercury (mmHg) | Standard Deviation 13.8 |
Secondary
Change in PASP, Baseline to 3-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 3-Year Visit | Baseline Visit | 44.2 millimeters of mercury (mmHg) | Standard Deviation 12.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 3-Year Visit | 6-Month Visit | 40.4 millimeters of mercury (mmHg) | Standard Deviation 12 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 3-Year Visit | Change from Baseline | -3.8 millimeters of mercury (mmHg) | Standard Deviation 14.9 |
Secondary
Change in PASP, Baseline to 4-Year Visit
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 4-Year Visit | Baseline Visit | 43.6 millimeters of mercury (mmHg) | Standard Deviation 13.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 4-Year Visit | 4-Year Visit | 40.7 millimeters of mercury (mmHg) | Standard Deviation 14.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 4-Year Visit | Change from Baseline | -2.8 millimeters of mercury (mmHg) | Standard Deviation 16.1 |
Secondary
Change in PASP, Baseline to 6-Month Visit
Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 6-Month Visit | Baseline Visit | 46.0 millimeters of mercury (mmHg) | Standard Deviation 12 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 6-Month Visit | 6-Month Visit | 40.2 millimeters of mercury (mmHg) | Standard Deviation 11 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in PASP, Baseline to 6-Month Visit | Change from Baseline | -5.8 millimeters of mercury (mmHg) | Standard Deviation 12 |
Secondary
Change in Tricuspid Regurgitation From Baseline
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 6-Month Visit | 3 Grade Increase | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 6-Month Visit | 2 Grade Increase | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 6-Month Visit | 1 Grade Increase | 14 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 6-Month Visit | No Change | 58 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 6-Month Visit | 1 Grade Decrease | 35 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 6-Month Visit | 2 Grade Decrease | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 6-Month Visit | 3 Grade Decrease | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 1-Year Visit | 3 Grade Increase | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 1-Year Visit | 2 Grade Increase | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 1-Year Visit | 1 Grade Increase | 8 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 1-Year Visit | No Change | 49 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 1-Year Visit | 1 Grade Decrease | 30 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 1-Year Visit | 2 Grade Decrease | 2 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 1-Year Visit | 3 Grade Decrease | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 2-Year Visit | 3 Grade Increase | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 2-Year Visit | 2 Grade Increase | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 2-Year Visit | 1 Grade Increase | 8 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 2-Year Visit | No Change | 40 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 2-Year Visit | 1 Grade Decrease | 18 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 2-Year Visit | 2 Grade Decrease | 2 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 2-Year Visit | 3 Grade Decrease | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 3-Year Visit | 3 Grade Increase | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 3-Year Visit | 2 Grade Increase | 4 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 3-Year Visit | 1 Grade Increase | 7 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 3-Year Visit | No Change | 34 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 3-Year Visit | 1 Grade Decrease | 12 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 3-Year Visit | 2 Grade Decrease | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 3-Year Visit | 3 Grade Decrease | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 4-Year Visit | 3 Grade Increase | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 4-Year Visit | 2 Grade Increase | 3 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 4-Year Visit | 1 Grade Increase | 4 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 4-Year Visit | No Change | 27 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 4-Year Visit | 1 Grade Decrease | 10 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 4-Year Visit | 2 Grade Decrease | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Change in Tricuspid Regurgitation From Baseline | 4-Year Visit | 3 Grade Decrease | 0 Participants |
Secondary
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.
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.
Time frame: 6 months, 1 year, 2 year, 3 year, 4 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | 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 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | 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 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | 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 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | 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 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | 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
EQ5D VAS Score by Study 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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | EQ5D VAS Score by Study Visit | Baseline Visit | 62.8 score on a scale | Standard Deviation 21.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | EQ5D VAS Score by Study Visit | 30-Day Visit | 74.3 score on a scale | Standard Deviation 19.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | EQ5D VAS Score by Study Visit | 6-Month Visit | 75.1 score on a scale | Standard Deviation 17.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | EQ5D VAS Score by Study Visit | 1-Year Visit | 73.4 score on a scale | Standard Deviation 20.3 |
Secondary
KCCQ OS Score by Study 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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | KCCQ OS Score by Study Visit | Baseline Visit | 54.6 score on a scale | Standard Deviation 21.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | KCCQ OS Score by Study Visit | 30-Day Visit | 70.7 score on a scale | Standard Deviation 17.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | KCCQ OS Score by Study Visit | 6-Month Visit | 71.7 score on a scale | Standard Deviation 15.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | KCCQ OS Score by Study Visit | 1-Year Visit | 72.0 score on a scale | Standard Deviation 16.7 |
Secondary
LVEDV by Study Visit
Left ventricular end diastolic volume (LVEDV) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVEDV by Study Visit | 2-Year Visit | 145.9 milliliters | Standard Deviation 58.5 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVEDV by Study Visit | Baseline Visit | 181.2 milliliters | Standard Deviation 60.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVEDV by Study Visit | 6-Month Visit | 166.2 milliliters | Standard Deviation 61.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVEDV by Study Visit | 1-Year Visit | 152.8 milliliters | Standard Deviation 55.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVEDV by Study Visit | 3-Year Visit | 151.3 milliliters | Standard Deviation 66.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVEDV by Study Visit | 4-Year Visit | 141.2 milliliters | Standard Deviation 63.3 |
Secondary
LVESV by Study Visit
Left ventricular end systolic volume (LVESV) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVESV by Study Visit | Baseline Visit | 108.7 milliliters | Standard Deviation 55.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVESV by Study Visit | 6-Month Visit | 100.6 milliliters | Standard Deviation 54 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVESV by Study Visit | 1-Year Visit | 91.1 milliliters | Standard Deviation 49.4 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVESV by Study Visit | 2-Year Visit | 86.0 milliliters | Standard Deviation 51.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVESV by Study Visit | 3-Year Visit | 91.9 milliliters | Standard Deviation 57.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | LVESV by Study Visit | 4-Year Visit | 82.3 milliliters | Standard Deviation 54.9 |
Secondary
Mitral EROA by Study 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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral EROA by Study Visit | Baseline Visit | 0.38 square centimeters | Standard Deviation 0.15 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral EROA by Study Visit | 30-Day Visit | 0.17 square centimeters | Standard Deviation 0.21 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral EROA by Study Visit | 3-Year Visit | 0.24 square centimeters | Standard Deviation 0.13 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral EROA by Study Visit | 6-Month Visit | 0.15 square centimeters | Standard Deviation 0.06 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral EROA by Study Visit | 1-Year Visit | 0.18 square centimeters | Standard Deviation 0.06 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral EROA by Study Visit | 2-Year Visit | 0.19 square centimeters | Standard Deviation 0.03 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral EROA by Study Visit | 4-Year Visit | 0.25 square centimeters | Standard Deviation 0.1 |
Secondary
Mitral Regurgitant Volume by Study 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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitant Volume by Study Visit | 6-Month Visit | 25.3 milliliters | Standard Deviation 11.2 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitant Volume by Study Visit | Baseline Visit | 57.3 milliliters | Standard Deviation 19.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitant Volume by Study Visit | 30-Day Visit | 25.2 milliliters | Standard Deviation 18.7 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitant Volume by Study Visit | 1-Year Visit | 30.1 milliliters | Standard Deviation 10.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitant Volume by Study Visit | 2-Year Visit | 31.0 milliliters | Standard Deviation 7.3 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitant Volume by Study Visit | 3-Year Visit | 38.0 milliliters | Standard Deviation 18.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitant Volume by Study Visit | 4-Year Visit | 37.8 milliliters | Standard Deviation 16.7 |
Secondary
Mitral Regurgitation Reduction
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | Baseline | None/Trace (0+) | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | Baseline | Mild (1+) | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | Baseline | Mild-Moderate (2+) | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | Baseline | Moderate-Severe (3+) | 66 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | Baseline | Severe (4+) | 57 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 30 Days | None/Trace (0+) | 18 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 30 Days | Mild (1+) | 72 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 30 Days | Mild-Moderate (2+) | 23 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 30 Days | Moderate-Severe (3+) | 2 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 30 Days | Severe (4+) | 2 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 6 Months | None/Trace (0+) | 17 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 6 Months | Mild (1+) | 64 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 6 Months | Mild-Moderate (2+) | 28 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 6 Months | Moderate-Severe (3+) | 2 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 6 Months | Severe (4+) | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 1 Year | None/Trace (0+) | 13 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 1 Year | Mild (1+) | 57 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 1 Year | Mild-Moderate (2+) | 22 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 1 Year | Moderate-Severe (3+) | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 1 Year | Severe (4+) | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 2 Years | None/Trace (0+) | 11 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 2 Years | Mild (1+) | 40 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 2 Years | Mild-Moderate (2+) | 18 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 2 Years | Moderate-Severe (3+) | 2 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 2 Years | Severe (4+) | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 3 Years | None/Trace (0+) | 10 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 3 Years | Mild (1+) | 32 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 3 Years | Mild-Moderate (2+) | 14 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 3 Years | Moderate-Severe (3+) | 3 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 3 Years | Severe (4+) | 0 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 4 Years | None/Trace (0+) | 9 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 4 Years | Mild (1+) | 28 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 4 Years | Mild-Moderate (2+) | 5 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 4 Years | Moderate-Severe (3+) | 2 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral Regurgitation Reduction | 4 Years | Severe (4+) | 1 Participants |
Secondary
NT-proBNP by Study Visit
N-terminal pro-B-type natriuretic peptide (NT-proBNP) level by study visit.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | NT-proBNP by Study Visit | Baseline Visit | 4148.7 picograms per milliliter (pg/ml) | Standard Deviation 6430.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | NT-proBNP by Study Visit | 6-Month Visit | 2835.0 picograms per milliliter (pg/ml) | Standard Deviation 3817.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | NT-proBNP by Study Visit | 1-Year Visit | 2620.2 picograms per milliliter (pg/ml) | Standard Deviation 3061.1 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | NT-proBNP by Study Visit | 2-Year Visit | 2038.2 picograms per milliliter (pg/ml) | Standard Deviation 2636.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | NT-proBNP by Study Visit | 3-Year Visit | 2425.2 picograms per milliliter (pg/ml) | Standard Deviation 2024.8 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | NT-proBNP by Study Visit | 4-Year Visit | 1837.6 picograms per milliliter (pg/ml) | Standard Deviation 1718 |
Secondary
PASP by Study Visit
Pulmonary artery systolic pressure (PASP) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | PASP by Study Visit | Baseline Visit | 46.4 millimeters of mercury (mmHg) | Standard Deviation 12.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | PASP by Study Visit | 6-Month Visit | 39.7 millimeters of mercury (mmHg) | Standard Deviation 11.2 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | PASP by Study Visit | 1-Year Visit | 39.9 millimeters of mercury (mmHg) | Standard Deviation 11.6 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | PASP by Study Visit | 2-Year Visit | 37.2 millimeters of mercury (mmHg) | Standard Deviation 11.9 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | PASP by Study Visit | 3-Year Visit | 39.8 millimeters of mercury (mmHg) | Standard Deviation 12.2 |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | PASP by Study Visit | 4-Year Visit | 39.6 millimeters of mercury (mmHg) | Standard Deviation 14.1 |
Secondary
Recurrent Heart Failure Hospitalization
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.
Time frame: 30 days , 6 months, 1 year, 2 year, 3 year, 4 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Recurrent Heart Failure Hospitalization | 4 years (site-reported) | 33 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Recurrent Heart Failure Hospitalization | 30 days | 3 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Recurrent Heart Failure Hospitalization | 6 months | 10 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Recurrent Heart Failure Hospitalization | 1 year | 15 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Recurrent Heart Failure Hospitalization | 2 year (site-reported) | 23 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Recurrent Heart Failure Hospitalization | 3 year (site-reported) | 29 Participants |
Secondary
Reintervention Rates for Mitral Regurgitation
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.
Time frame: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Reintervention Rates for Mitral Regurgitation | 30 days | 1 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Reintervention Rates for Mitral Regurgitation | 6 months | 2 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Reintervention Rates for Mitral Regurgitation | 1 year | 2 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Reintervention Rates for Mitral Regurgitation | 2 year (site-reported) | 3 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Reintervention Rates for Mitral Regurgitation | 3 year (site-reported) | 4 Participants |
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Reintervention Rates for Mitral Regurgitation | 4 years (site-reported) | 6 Participants |