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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Sponsor: Edwards Lifesciences
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)
Official title: Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): 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 Mitral Regurgitation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1247
Start Date
2018-11-30
Completion Date
2031-06-30
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Edwards PASCAL System
Transcatheter mitral valve repair with the Edwards PASCAL System
Abbott Mitraclip System
Transcatheter mitral valve repair with the Abbott Mitraclip System
Locations (86)
Banner University Medical Center
Phoenix, Arizona, United States
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
TMC Healthcare
Tucson, Arizona, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UC Irvine
Orange, California, United States
Sutter Medical Center-Sacramento
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
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, United States
Mount Sinai
Miami Beach, Florida, United States
NCH Rooney Heart Institute
Naples, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Emory University Hospital and Emory University Hospital Midtown
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
St. Vincent Heart Center
Carmel, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 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
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
St 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
State University of New York at Buffalo
Buffalo, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
NYU Langone Health
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Lenox Hill Hospital and North Shore University
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oklahoma Cardiovascular
Oklahoma City, Oklahoma, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg
Wormleysburg, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
WellSpan York Hospital
York, Pennsylvania, United States
CVA Heart Institute Kingsport
Kingsport, Tennessee, 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
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
Swedish Medical Center
Seattle, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
St. Pauls Hospital
Vancouver, British Columbia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, 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