Growing heart valve could spare kids repeat surgeries

NCT ID NCT05006404

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

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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