New heart valve fix could spare thousands from Open-Heart surgery

NCT ID NCT03130777

Ongoing Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device (Alterra Prestent) used with a replacement heart valve (SAPIEN 3) to fix a leaky pulmonary valve in people born with heart defects. About 86 participants with moderate or severe leakage will get the device through a tube in a blood vessel, avoiding open-heart surgery. The goal is to see if the valve works well and stays in place, reducing leakage and improving heart function.

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Conditions

The condition(s) this trial relates to.

congenital heart disease lung disorder pulmonary valve insufficiency tetralogy of fallot

As listed by the trial registrant

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

CONGENITAL HEART DISEASE PULMONARY DISEASE PULMONARY REGURGITATION TETRALOGY OF FALLOT TRANSCATHETER PULMONARY VALVE REPLACEMENT (TPVR)

Contacts and locations

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Locations

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Children's Health Dallas

Dallas, Texas, 75235, United States
Children's Hospital Colorado

Aurora, Colorado, 80045, United States
Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States
Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States
Columbia University Medical Center

New York, New York, 10032, United States
Emory University/ Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia, 30322, United States
Nationwide Children's Hospital

Columbus, Ohio, 43205, United States
Seattle Children's Hospital

Seattle, Washington, 98105, United States
St. Louis Children's Hospital

St Louis, Missouri, 63110, United States
Texas Children's Hospital

Houston, Texas, 77030, United States
University of California, Los Angeles

Los Angeles, California, 90095, United States
University of California, San Francisco

San Francisco, California, 94122, United States
University of Virgina

Charlottesville, Virginia, 22908, United States

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