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RECRUITING

NCT04097145

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Sponsor: Edwards Lifesciences

View on ClinicalTrials.gov

Summary

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Official title: A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

870

Start Date

2019-12-11

Completion Date

2031-12-31

Last Updated

2026-04-06

Healthy Volunteers

Conditions

Tricuspid Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease

Interventions

DEVICE

Edwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy

DRUG

Optimal Medical Therapy

Optimal Medical Therapy alone in patients with tricuspid regurgitation

DEVICE

Edwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT

DEVICE

Edwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Inclusion Criteria: * Eighteen (18) years of age or older * Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. * Severe or greater tricuspid regurgitation * New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months * Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team * Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements Exclusion Criteria: * Tricuspid valve anatomy not evaluable by TTE or TEE * Tricuspid valve anatomy precludes proper device deployment and function * Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure) * Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following: 1. Would prevent proper TR reduction due to interaction of the lead with the leaflets 2. Were implanted in the RV within the last 90 days prior to the point of enrollment * Primary non-degenerative tricuspid disease * Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL * Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction * Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment * Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days * Recent Stroke * Active gastrointestinal (GI) bleeding * Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV * Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days * Any of the following cardiovascular procedures: 1. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment 2. Carotid surgery within 30 days prior to the point of enrollment 3. Direct current cardioversion within the last 30 days prior to the point of enrollment 4. Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment 5. Cardiac surgery within 90 days prior to the point of enrollment * Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation * Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis * Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days * Patient is oxygen-dependent or requires continuous home oxygen * Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days) * 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 * Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship * Any patient considered to be vulnerable

Locations (79)

Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Tucson Medical Center Healthcare

Tucson, Arizona, United States

University of California, Irvine

Irvine, California, United States

SCPMG - Kaiser San Diego

La Jolla, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, 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

St. Joseph Hospital

Denver, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

NCH Healthcare System

Naples, Florida, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Emory University Hospital Midtown / Emory University - St. Joseph's Hospital

Atlanta, Georgia, United States

Piedmont Healthcare, Inc.

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Ascension St. Vincent Heart Center Cardiovascular Research Institute

Indianapolis, Indiana, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

William Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States

St. Mary's of Ascension Research

Saginaw, Michigan, United States

Fairview Health Services

Maplewood, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Providence St. Patrick Hospital

Missoula, Montana, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Cooper Health Systems

Camden, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

State University of New York at Buffalo

Buffalo, New York, United States

Columbia University Irving Medical Center/NYPH

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset

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 / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital

The Bronx, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Sanford Medical Center Fargo

Fargo, North Dakota, United States

The Christ Hospital

Cincinnati, Ohio, United States

TriHealth-Bethesda North Hospital

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Oklahoma Heart Institute at Hillcrest Medical Center

Tulsa, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Penn State Hershey

Hershey, Pennsylvania, United States

Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Pinnacle Health Cardiovascular Institute/UPMC Pinnacle

Wormleysburg, Pennsylvania, United States

Lankenau Heart Institute

Wynnewood, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Erlanger Health System

Chattanooga, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

HCA Houston Healthcare Medical Center

Houston, Texas, United States

Baylor College of Medicine St. Luke's Medical Center

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

UTHealth/Memorial Hermann Hospital

Houston, Texas, United States

Baylor Scott & White - The Heart Hospital - Plano

Plano, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

St. George Regional Hospital

St. George, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Carilion Medical Center

Roanoke, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

St. Paul's Hospital

Vancouver, British Columbia, Canada

Hamilton Health Services

Hamilton, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, Canada

Clinical Research Directory

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (79)