Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
- Conditions
- Degenerative Mitral Valve DiseaseMitral RegurgitationMitral InsufficiencyFunctional Mitral Regurgitation
- Interventions
- Device: Edwards PASCAL SystemDevice: Abbott Mitraclip System
- Registration Number
- NCT03706833
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
- Detailed Description
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1247
- Eighteen (18) years of age or older
- Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
- Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
- Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
- Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
- Mitral regurgitation (3+ to 4+) by echo
- Suitable valve and regurgitant jet morphology
- Elevated corrected BNP > 400 pg/ml or corrected NT-pro BNP of > 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
- LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)
- Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
- Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
- Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)
- Clinically significant, untreated coronary artery disease
- Recent stroke
- Other severe valve disorders requiring intervention
- Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
- Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
- Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
- Active rheumatic heart disease or rheumatic etiology for MR
- Severe aortic stenosis or regurgitation
- Known history of untreated, severe carotid stenosis
- Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)
- Severe COPD
- Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
- Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
- Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Edwards PASCAL System - CLASP IID Edwards PASCAL System Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation Edwards PASCAL System - CLASP IIF Edwards PASCAL System Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation Abbott Mitraclip System - CLASP IID Abbott Mitraclip System Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation Abbott Mitraclip System - CLASP IIF Abbott Mitraclip System Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation Edwards PASCAL System - Single-Arm Registry Edwards PASCAL System Transcatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system.
- Primary Outcome Measures
Name Time Method PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only. From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs). 30 days. PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort. 6 months
- Secondary Outcome Measures
Name Time Method Functional Improvement (increase in 6 minute walk test in meters) 30 days , 6 months, 1 year Increase in 6 minute walk test in meters
Rates of various adverse events 6 months; 12 months Rates of various adverse events at 6 and 12 months
Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years 30 days , 6 months, 1 year, 2 year Number of points of improvement on a scale of 0-100 in Kansas City Cardiomyopathy Questionnaire, with higher scores associated with higher Quality of Life
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through 30 days, 6 months, 1 year, 2 year Number of points of improvement on a scale of 1-100 in Short Form Health Survey (EQ-5D-5L) questionnaire, with higher totals associated with higher Quality of Life
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years 30 days, 6 months, 1 year, 2 year Number of points of improvement on a scale of 0-100 in Short Form Health Survey (SF-36) questionnaire, with higher totals associated with higher Quality of Life
Trial Locations
- Locations (103)
Los Robles Hospital and Medical Center
🇺🇸Thousand Oaks, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
The Cardiac and Vascular Institute Research Foundation
🇺🇸Gainesville, Florida, United States
Mount Sinai
🇺🇸Miami Beach, Florida, United States
NCH Healthcare System Naples
🇺🇸Naples, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Banner University Medical Center
🇺🇸Phoenix, Arizona, United States
Abrazo Arizona Heart Hospital
🇺🇸Phoenix, Arizona, United States
Arizona Cardiovascular Research Center
🇺🇸Phoenix, Arizona, United States
TMC Healthcare
🇺🇸Tucson, Arizona, United States
Scripps Memorial Hospital La Jolla
🇺🇸La Jolla, California, United States
PIH Health Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
St. Joseph Hospital
🇺🇸Orange, California, United States
UC Irvine
🇺🇸Orange, California, United States
Sutter Medical Center-Sacramento
🇺🇸Sacramento, California, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Sutter Bay Area
🇺🇸San Francisco, California, United States
Kaiser Permanente San Francisco
🇺🇸San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
Emory University Hospital and Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Advocate Health & Hospitals Corp/Edward Heart Hospital
🇺🇸Naperville, Illinois, United States
St. Vincent Heart Center
🇺🇸Carmel, Indiana, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Cardiovascular Research Institute of Kansas
🇺🇸Wichita, Kansas, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Woman's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Fairview Health Services
🇺🇸Maplewood, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
CentraCare Heart and Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
St.Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Washington University/Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Rutgers-RWJMS
🇺🇸New Brunswick, New Jersey, United States
Albany Medical College
🇺🇸Albany, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
State University of New York at Buffalo
🇺🇸Buffalo, New York, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
WellSpan York Hospital
🇺🇸York, Pennsylvania, United States
Baptist Memorial Hospital Memphis
🇺🇸Memphis, Tennessee, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Saint Thomas Heart at Saint Thomas West
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Medical City Dallas
🇺🇸Dallas, Texas, United States
NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
Lenox Hill Hospital and North Shore University
🇺🇸New York, New York, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg
🇺🇸Wormleysburg, Pennsylvania, United States
NYU Langone Health
🇺🇸New York, New York, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Integris Health Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Cardiovascular
🇺🇸Oklahoma City, Oklahoma, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Columbia University Medical Center/New York Presbyterian Hospital
🇺🇸New York, New York, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Atrium Health/Sanger Heart & Vascular Institute
🇺🇸Charlotte, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
HCA Houston Healthcare Medical Center
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Chippenham Johnston & Willis Medical Center
🇺🇸Richmond, Virginia, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
University of Washington
🇺🇸Seattle, Washington, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
St. Pauls Hospital
🇨🇦Vancouver, British Columbia, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) ULaval
🇨🇦Québec, Canada
Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum
🇩🇪Bad Oeynhausen, Germany
Herzzentrum Universitätsklinikum Koln
🇩🇪Cologne, Germany
Herrzentrum Dresden GmbH Universitätklinik an der Technischen Universität Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Essen (AöR) Klinik für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum
🇩🇪Essen, Germany
Universitätsklinikum Gießen Medizinische Klinik I, Innere Medizin/ Kardiologie
🇩🇪Gießen, Germany
Universitäres Herzzentrum Hamburg GmbH (UHZ) Klinik und Poliklinik für Allgemeneine und Interventionelle Kardiologie
🇩🇪Hamburg, Germany
Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie, Pneumologie
🇩🇪Heidelberg, Germany
Herzzentrum Leipzig Universitätsklinik für Kardiologie
🇩🇪Leipzig, Germany
Zentrum für Kardiologie - Kardiologie I Universitätsmedizin der Johannes Gutenberg Universität Mainz
🇩🇪Mainz, Germany
Medizinische Klinik I LMU München Campus Grosshadern
🇩🇪München, Germany
Helios Klinikum Siegburg
🇩🇪Siegburg, Germany
ULM University Zentrum für Innere Medizin Klinik für Innere Medizin II
🇩🇪Ulm, Germany
University Hospital Bern
🇨🇭Bern, Switzerland