New heart valve repair device could spare patients from major surgery

NCT ID NCT04097145

Recruiting now Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests a device called the Edwards PASCAL System, which is threaded through a blood vessel to repair a leaky tricuspid valve in the heart. It is for people with severe symptoms who are not good candidates for open-heart surgery. About 1,270 participants will be randomly assigned to get the device plus medication, or medication alone, to see if the device improves survival, reduces hospital stays, and boosts quality of life.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Edwards PASCAL Transcatheter Valve Repair System (a device inserted through a blood vessel to repair the tricuspid valve)
What this could lead to: If successful, this could offer a less invasive treatment option for people with severe tricuspid valve leakage who are too high-risk for surgery, potentially reducing symptoms and hospitalizations.
What could go wrong: This is a pivotal trial but still experimental. The device may not work for everyone, and risks include complications from the procedure itself. It is not a cure, as patients may still need ongoing medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

TRICUSPID REGURGITATION TRICUSPID VALVE DISEASE TRICUSPID VALVE INSUFFICIENCY

Contacts and locations

Locations

Ascension St. Vincent Heart Center Cardiovascular Research Institute
RECRUITING

Indianapolis, Indiana, 46290, United States
Banner University Medical Center Phoenix
ACTIVE_NOT_RECRUITING

Phoenix, Arizona, 85006, United States
Baylor College of Medicine St. Luke's Medical Center
RECRUITING

Houston, Texas, 77030, United States
Baylor Scott & White - The Heart Hospital - Plano
RECRUITING

Plano, Texas, 75093, United States
Carilion Medical Center
RECRUITING

Roanoke, Virginia, 24014, United States
Cedars Sinai Medical Center
ACTIVE_NOT_RECRUITING

Los Angeles, California, 90048, United States
Columbia University Irving Medical Center/NYPH
RECRUITING

New York, New York, 10032, United States
Cooper Health Systems
RECRUITING

Camden, New Jersey, 09103, United States
Dartmouth-Hitchcock Medical Center
RECRUITING

Lebanon, New Hampshire, 03756, United States
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital
RECRUITING

Atlanta, Georgia, 30308, United States
Erlanger Health System
ACTIVE_NOT_RECRUITING

Chattanooga, Tennessee, 37403, United States
Fairview Health Services
ACTIVE_NOT_RECRUITING

Maplewood, Minnesota, 55109, United States
HCA Houston Healthcare Medical Center
RECRUITING

Houston, Texas, 77004, United States
Hamilton Health Services
ACTIVE_NOT_RECRUITING

Hamilton, Ontario, L8L 2X2, Canada
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
ACTIVE_NOT_RECRUITING

Québec, Quebec, G1V 4G5, Canada
Integris Baptist Medical Center
ACTIVE_NOT_RECRUITING

Oklahoma City, Oklahoma, 73112, United States
Intermountain Medical Center
ACTIVE_NOT_RECRUITING

Murray, Utah, 84107, United States
Johns Hopkins
RECRUITING

Baltimore, Maryland, 21287, United States
Kaiser Permanente San Francisco
ACTIVE_NOT_RECRUITING

San Francisco, California, 94118, United States
Lankenau Heart Institute
RECRUITING

Wynnewood, Pennsylvania, 19096, United States
Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset
RECRUITING

New York, New York, 10075, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
Medical Center of the Rockies
ACTIVE_NOT_RECRUITING

Loveland, Colorado, 80538, United States
Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina
ACTIVE_NOT_RECRUITING

Charleston, South Carolina, 29245, United States
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital
RECRUITING

The Bronx, New York, 10467, United States
Morristown Medical Center
RECRUITING

Morristown, New Jersey, 07962, United States
Mount Sinai Medical Center
RECRUITING

Miami Beach, Florida, 33140, United States
NCH Healthcare System
RECRUITING

Naples, Florida, 34102, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States
Ochsner Medical Center
ACTIVE_NOT_RECRUITING

New Orleans, Louisiana, 70121, United States
Oklahoma Cardiovascular Research Group
RECRUITING

Oklahoma City, Oklahoma, 73120, United States
Oklahoma Heart Institute at Hillcrest Medical Center
RECRUITING

Tulsa, Oklahoma, 74104, United States
Oregon Health & Science University
RECRUITING

Portland, Oregon, 97239, United States
Penn State Hershey
RECRUITING

Hershey, Pennsylvania, 17033, United States
Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Piedmont Healthcare, Inc.
ACTIVE_NOT_RECRUITING

Atlanta, Georgia, 30309, United States
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle
RECRUITING

Wormleysburg, Pennsylvania, 17043, United States
Providence St. Patrick Hospital
ACTIVE_NOT_RECRUITING

Missoula, Montana, 59802, United States
Rochester General Hospital
ACTIVE_NOT_RECRUITING

Rochester, New York, 14621, United States
Rutgers Robert Wood Johnson Medical School
RECRUITING

New Brunswick, New Jersey, 08901, United States
SCPMG - Kaiser San Diego
ACTIVE_NOT_RECRUITING

La Jolla, California, 92037, United States
Saint Luke's Hospital of Kansas City
RECRUITING

Kansas City, Missouri, 64111, United States
Sanford Medical Center Fargo
ACTIVE_NOT_RECRUITING

Fargo, North Dakota, 58104, United States
Sarasota Memorial Health Care System
RECRUITING

Sarasota, Florida, 34239, United States
St. Francis Hospital
RECRUITING

Roslyn, New York, 11576, United States
St. George Regional Hospital
RECRUITING

St. George, Utah, 84790, United States
St. Joseph Hospital
RECRUITING

Denver, Colorado, 80218, United States
St. Mary's of Ascension Research
ACTIVE_NOT_RECRUITING

Saginaw, Michigan, 48601, United States
St. Michael's Hospital
ACTIVE_NOT_RECRUITING

Toronto, Ontario, M5B 1W8, Canada
St. Paul's Hospital
ACTIVE_NOT_RECRUITING

Vancouver, British Columbia, V6Z 1Y6, Canada
Stanford University
ACTIVE_NOT_RECRUITING

Stanford, California, 94305, United States
State University of New York at Buffalo
RECRUITING

Buffalo, New York, 14203, United States
Sunnybrook Health Sciences Centre
ACTIVE_NOT_RECRUITING

Toronto, Ontario, M4N 3M5, Canada
Swedish Medical Center
ACTIVE_NOT_RECRUITING

Seattle, Washington, 98122, United States
Tallahassee Research Institute
ACTIVE_NOT_RECRUITING

Tallahassee, Florida, 32308, United States
The Cardiac and Vascular Institute Research Foundation
RECRUITING

Gainesville, Florida, 32605, United States
The Christ Hospital
RECRUITING

Cincinnati, Ohio, 45219, United States
The Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States
The University of Texas Health Science Center at Houston
RECRUITING

Houston, Texas, 77030, United States
TriHealth-Bethesda North Hospital
ACTIVE_NOT_RECRUITING

Cincinnati, Ohio, 45242, United States
Tucson Medical Center Healthcare
ACTIVE_NOT_RECRUITING

Tucson, Arizona, 85712, United States
UCLA Medical Center
ACTIVE_NOT_RECRUITING

Los Angeles, California, 90095, United States
UTHealth/Memorial Hermann Hospital
RECRUITING

Houston, Texas, 77030, United States
University of California, Irvine
RECRUITING

Irvine, California, 92868, United States
University of California, San Francisco
RECRUITING

San Francisco, California, 94143, United States
University of Iowa Hospitals & Clinics
ACTIVE_NOT_RECRUITING

Iowa City, Iowa, 52242, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of North Carolina
RECRUITING

Chapel Hill, North Carolina, 27517, United States
University of Ottawa Heart Institute
ACTIVE_NOT_RECRUITING

Ottawa, Ontario, K1Y 4Q7, Canada
University of Virginia Health System
RECRUITING

Charlottesville, Virginia, 22908, United States
Vanderbilt University Medical Center
ACTIVE_NOT_RECRUITING

Nashville, Tennessee, 37212, United States
Virginia Commonwealth University
ACTIVE_NOT_RECRUITING

Richmond, Virginia, 23298, United States
Virginia Mason Medical Center
RECRUITING

Seattle, Washington, 98101, United States
Washington University School of Medicine
ACTIVE_NOT_RECRUITING

St Louis, Missouri, 63110, United States
Weill Cornell Medicine
RECRUITING

New York, New York, 10065, United States
William Beaumont Hospital - Royal Oak
ACTIVE_NOT_RECRUITING

Royal Oak, Michigan, 48073, United States

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