The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
- Conditions
- Mitral Valve Regurgitation
- Interventions
- Device: Mitral Valve Repair
- Registration Number
- NCT03170349
- Lead Sponsor
- Edwards Lifesciences
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 124
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Edwards PASCAL Transcatheter Mitral Valve Repair System Mitral Valve Repair -
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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
Mitral Regurgitation Reduction Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 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 All-cause mortality at 30 days, 6 months, 1 year and annually thereafter
Note: The 3-year total of 31 deaths does not include 2 deaths occurring after 3 years (1095 days) post-implant but before the end of the 3-Year visit window (1095 ± 45 days) at 1140 days post-implant.Recurrent Heart Failure Hospitalization 30 days , 6 months, 1 year, 2 year, 3 year Recurrent heart failure hospitalization at 30 days, 6 months, 1 year and annually thereafter
Reintervention Rates for Mitral Regurgitation 30 days, 6 months, 1 year, 2 year, 3 year Reintervention rates for mitral regurgitation at 30 days, 6 months, 1 year and annually thereafter
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 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
LVEDV by Study Visit Baseline, 6 Months, 1 Year, 2 Years and 3 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
LVESV by Study Visit Baseline, 6 Months, 1 Year, 2 Years and 3 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
PASP by Study Visit Baseline, 6 Months, 1 Year, 2 Years and 3 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
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 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 and 3 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 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
BNP by Study Visit Baseline, 6 Months, 1 Year, 2 Years and 3 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 Tricuspid Regurgitation From Baseline 6 Month, 1 Year, 2 Years, 3 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 and 3 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
Mitral Regurgitant Volume by Study Visit Baseline, 30 Days, 6 Months, 1 Year, 2 Years and 3 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
Trial Locations
- Locations (17)
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
Sunnybrook Hospital
🇨🇦Toronto, Ontario, Canada
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
St Michael Hospital
🇨🇦Toronto, Ontario, Canada
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, 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
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
St. Paul's Hospital, Providence Health Care Research Institute
🇨🇦Vancouver, British Columbia, Canada
Inselspital, University Hospital Bern
🇨🇭Bern, Switzerland
Hygeia Hospital
🇬🇷Athens, Greece
San Rafaelle Hospital
🇮🇹Milano, Italy
Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie
🇩🇪Bonn, Germany
University of Colorado Denver
🇺🇸Aurora, Colorado, United States