Growing heart valve could spare kids repeat surgeries

NCT ID NCT05006404

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

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests a special heart valve for children aged 1.5 to 16 years with congenital heart disease who need a pulmonary valve replacement. The valve can be expanded after implant to match the child's growth, potentially avoiding multiple surgeries. Researchers will check safety and how well the valve works over 10 years.

What this could mean

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

Active substance: Autus Size-Adjustable Valve (a heart valve device that can be expanded to fit a growing child)
What this could lead to: If successful, this valve could reduce the number of repeat surgeries children need as they grow, offering a more adaptable solution for heart valve replacement.
What could go wrong: This is an early-stage study with only 51 participants, so results may not apply to all children. Risks include device-related complications like blood clots or valve failure.

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.

congenital heart disease pulmonary valve disorder

As listed by the trial registrant

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

CONGENITAL HEART DISEASE

Contacts and locations

Locations

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States
Boston Children's Hospital

Boston, Massachusetts, 02115, United States
Children's Healthcare of Atlanta

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

Aurora, Colorado, 80045, United States
Children's Hospital Los Angeles

Los Angeles, California, 90027, United States
Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States
Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032, United States
Duke University

Durham, North Carolina, 27703, United States
Nationwide Children's Hospital

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

Seattle, Washington, 98105, United States
University of Michigan - Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States
University of Utah - Intermountain Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

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