New heart valve trial offers hope for patients with rare congenital defects

NCT ID NCT02744677

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

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study is testing a new heart valve (SAPIEN 3) in 108 people who have a dysfunctional right ventricle outflow tract (RVOT) due to a congenital heart defect or a previous valve replacement. The goal is to see if the valve is safe and effective at improving blood flow and reducing leakage. Participants must be at least 20 kg and have a specific landing zone size for the valve.

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Conditions

The condition(s) this trial relates to.

Aortic Valve Disease congenital heart disease persistent truncus arteriosus Pulmonary Atresia pulmonary valve insufficiency pulmonary valve stenosis tetralogy of fallot transposition of the great arteries

As listed by the trial registrant

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

COMPLEX CONGENITAL HEART DEFECT DYSFUNCTIONAL RVOT CONDUIT PULMONARY VALVE DEGENERATION PULMONARY VALVE INSUFFICIENCY

Contacts and locations

Locations

Arkansas Children's Hospital
RECRUITING

Little Rock, Arkansas, 72202, United States
Boston Children's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Children's Health System of Texas / UT Southwestern Medical Center
RECRUITING

Dallas, Texas, 75235, United States
Childrens Hospital of Colorado
RECRUITING

Aurora, Colorado, 80045, United States
Cincinnati Children's Hospital
RECRUITING

Cincinnati, Ohio, 45229, United States
Columbia University Medical Center/NYPH
RECRUITING

New York, New York, 10032, United States
Duke University Medical Center
RECRUITING

Durham, North Carolina, 27710, United States
Emory University/Children's Healthcare of Atlanta
RECRUITING

Atlanta, Georgia, 30322, United States
Intermountain Heart Institute (IMC)
RECRUITING

Murray, Utah, 84107, United States
LeBonheur Children's Hopsital
RECRUITING

Memphis, Tennessee, 38103, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic Rochester
RECRUITING

Rochester, Minnesota, 55905, United States
Medical City Dallas
RECRUITING

Dallas, Texas, 75230, United States
Methodist San Antonio
RECRUITING

San Antonio, Texas, 78229, United States
Nationwide Children's Hospital
RECRUITING

Columbus, Ohio, 43205, United States
Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia
COMPLETED

Philadelphia, Pennsylvania, 19104, United States
St. Louis Children's Hospital
RECRUITING

St Louis, Missouri, 63110, United States
The Lindner Research Center at Christ Hospital
COMPLETED

Cincinnati, Ohio, 45219, United States
UPMC Children's Hospital of Pittsburgh
RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
University of Alabama at Birmingham
RECRUITING

Birmingham, Alabama, 35233, United States
University of California, Los Angeles
COMPLETED

Los Angeles, California, 90095, United States
University of California,, San Francisco (UCSF)
RECRUITING

San Francisco, California, 94143, United States
University of Kentucky
WITHDRAWN

Lexington, Kentucky, 40536, United States
University of Virginia (UVA)
RECRUITING

Charlottesville, Virginia, 22908, United States
University of Washington/Seattle Children's Hospital
COMPLETED

Seattle, Washington, 98195, United States
Vanderbilt University
RECRUITING

Nashville, Tennessee, 37232, United States
Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
COMPLETED

St Louis, Missouri, 63110, United States

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