The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

Edwards Lifesciences124 enrolled

Overview

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

124

Conditions

Mitral Valve Regurgitation

Interventions

Mitral Valve RepairDEVICE

Minimal Invasive Transcatheter Mitral Valve Repair

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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

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

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

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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NorthShore University HealthSystem

Evanston, Illinois, United States

Henry Ford Hospital

Detroit, Michigan, United States

Morristown Medical Center

Morristown, New Jersey, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Metro North Hospital & Health Service, The Prince Charles Hospital

Brisbane, Chermside, Australia

Sydney Local Health District, Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

...and 7 more locations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

6MWD by Study Visit

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

Time frame: Baseline, 6 Months and 1 Year

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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