No-Scalpel heart valve replacement shows promise for leaky hearts
NCT ID NCT02979587
First seen Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 34 times
Summary
This study is testing a new type of heart valve, called the Harmony TPV, that can be placed using a thin tube (catheter) instead of open-heart surgery. It is designed for people with congenital heart disease who have a leaky pulmonary valve. The study involves 86 participants and is checking how safe and effective the valve is over time, including how well it works after 30 days and 6 months.
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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.
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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Contacts and locations
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Locations
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Mayo Clinic
Rochester, Minnesota, 55902, United States
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National Cerebral and Cardiovascular Center
Suita, Osaka, 565-8565, Japan
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Nationwide Children's Hospital
Columbus, Ohio, 43215, United States
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Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
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Ronald Regan UCLA Medical Center
Los Angeles, California, 90095, United States
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Seattle Children's Hospital
Seattle, Washington, 98105, United States
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Stanford University Medical Center
Palo Alto, California, 94304, United States
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Texas Children's Hospital
Houston, Texas, 77030, United States
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The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8, Canada
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Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
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Yale University
New Haven, Connecticut, 06510, United States
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Harmony Transcatheter Pulmonary Valve (a replacement heart valve made from pig tissue and metal frame, delivered via a catheter without open-heart surgery)
What this could lead to
If successful, this could provide a less invasive option for replacing leaky pulmonary valves in people with congenital heart disease, avoiding repeat open-heart surgeries.
What could go wrong
This is a post-approval study with only 86 participants, so results may not apply to everyone. Risks include device-related complications or the valve not working as well over time.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.