870
Participants
Start Date
December 11, 2019
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2031
Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Optimal Medical Therapy
Optimal Medical Therapy alone in patients with tricuspid regurgitation
Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
RECRUITING
Columbia University Irving Medical Center/NYPH, New York
RECRUITING
Weill Cornell Medicine, New York
RECRUITING
Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset, New York
RECRUITING
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital, The Bronx
RECRUITING
St. Francis Hospital, Roslyn
RECRUITING
State University of New York at Buffalo, Buffalo
ACTIVE_NOT_RECRUITING
Rochester General Hospital, Rochester
RECRUITING
Penn State Hershey, Hershey
RECRUITING
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle, Wormleysburg
RECRUITING
Lankenau Heart Institute, Wynnewood
RECRUITING
Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania, Philadelphia
RECRUITING
Johns Hopkins, Baltimore
RECRUITING
University of Virginia Health System, Charlottesville
ACTIVE_NOT_RECRUITING
Virginia Commonwealth University, Richmond
RECRUITING
Carilion Medical Center, Roanoke
RECRUITING
University of North Carolina, Chapel Hill
ACTIVE_NOT_RECRUITING
Medical University of South Carolina, Charleston
RECRUITING
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital, Atlanta
ACTIVE_NOT_RECRUITING
Piedmont Healthcare, Inc., Atlanta
RECRUITING
Tallahassee Research Institute, Tallahassee
RECRUITING
The Cardiac and Vascular Institute Research Foundation, Gainesville
RECRUITING
Mount Sinai Medical Center, Miami Beach
RECRUITING
NCH Healthcare System, Naples
RECRUITING
Sarasota Memorial Health Care System, Sarasota
ACTIVE_NOT_RECRUITING
Vanderbilt University Medical Center, Nashville
ACTIVE_NOT_RECRUITING
Erlanger Health System, Chattanooga
RECRUITING
The Ohio State University, Columbus
RECRUITING
The Christ Hospital, Cincinnati
ACTIVE_NOT_RECRUITING
TriHealth-Bethesda North Hospital, Cincinnati
RECRUITING
Ascension St. Vincent Heart Center Cardiovascular Research Institute, Indianapolis
RECRUITING
William Beaumont Hospital - Royal Oak, Royal Oak
RECRUITING
University of Michigan, Ann Arbor
RECRUITING
Henry Ford Hospital, Detroit
ACTIVE_NOT_RECRUITING
St. Mary's of Ascension Research, Saginaw
ACTIVE_NOT_RECRUITING
University of Iowa Hospitals & Clinics, Iowa City
RECRUITING
Medical College of Wisconsin, Milwaukee
ACTIVE_NOT_RECRUITING
Fairview Health Services, Maplewood
RECRUITING
Mayo Clinic, Rochester
ACTIVE_NOT_RECRUITING
Sanford Medical Center Fargo, Fargo
ACTIVE_NOT_RECRUITING
Providence St. Patrick Hospital, Missoula
RECRUITING
Northwestern University, Chicago
RECRUITING
Washington University School of Medicine, St Louis
RECRUITING
Saint Luke's Hospital of Kansas City, Kansas City
ACTIVE_NOT_RECRUITING
Ochsner Medical Center, New Orleans
ACTIVE_NOT_RECRUITING
Integris Baptist Medical Center, Oklahoma City
RECRUITING
Oklahoma Cardiovascular Research Group, Oklahoma City
RECRUITING
Oklahoma Heart Institute at Hillcrest Medical Center, Tulsa
RECRUITING
Baylor Scott & White - The Heart Hospital - Plano, Plano
RECRUITING
HCA Houston Healthcare Medical Center, Houston
RECRUITING
Baylor College of Medicine St. Luke's Medical Center, Houston
RECRUITING
The University of Texas Health Science Center at Houston, Houston
RECRUITING
UTHealth/Memorial Hermann Hospital, Houston
RECRUITING
St. Joseph Hospital, Denver
ACTIVE_NOT_RECRUITING
Medical Center of the Rockies, Loveland
ACTIVE_NOT_RECRUITING
Intermountain Medical Center, Murray
RECRUITING
St. George Regional Hospital, St. George
ACTIVE_NOT_RECRUITING
Banner University Medical Center Phoenix, Phoenix
ACTIVE_NOT_RECRUITING
Tucson Medical Center Healthcare, Tucson
RECRUITING
Cedars Sinai Medical Center, Los Angeles
RECRUITING
UCLA Medical Center, Los Angeles
ACTIVE_NOT_RECRUITING
SCPMG - Kaiser San Diego, La Jolla
RECRUITING
University of California, Irvine, Irvine
ACTIVE_NOT_RECRUITING
Kaiser Permanente San Francisco, San Francisco
RECRUITING
University of California, San Francisco, San Francisco
ACTIVE_NOT_RECRUITING
Stanford University, Stanford
RECRUITING
Oregon Health & Science University, Portland
RECRUITING
Virginia Mason Medical Center, Seattle
RECRUITING
Swedish Medical Center, Seattle
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
Dartmouth-Hitchcock Medical Center, Lebanon
RECRUITING
Cooper Health Systems, Camden
RECRUITING
Morristown Medical Center, Morristown
RECRUITING
Rutgers Robert Wood Johnson Medical School, New Brunswick
ACTIVE_NOT_RECRUITING
St. Paul's Hospital, Vancouver
ACTIVE_NOT_RECRUITING
Hamilton Health Services, Hamilton
ACTIVE_NOT_RECRUITING
University of Ottawa Heart Institute, Ottawa
ACTIVE_NOT_RECRUITING
Sunnybrook Health Sciences Centre, Toronto
ACTIVE_NOT_RECRUITING
St. Michael's Hospital, Toronto
ACTIVE_NOT_RECRUITING
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval, Québec
Lead Sponsor
Edwards Lifesciences
INDUSTRY