New No-Scalpel heart valve offers hope for leaky hearts

NCT ID NCT02979587

Ongoing Disease control Sponsor: Medtronic Heart Valves Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing a new type of heart valve called the Harmony TPV, which is placed using a thin tube (catheter) instead of open-heart surgery. It is for people with congenital heart disease who have a leaky pulmonary valve. The study will check if the valve works well and is safe over time, including how well it controls blood flow and whether it causes serious problems. About 86 participants are being followed long-term.

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 through a catheter)
What this could lead to: If successful, this could provide a less invasive option for replacing a leaky pulmonary valve, avoiding open-heart surgery for many patients with congenital heart disease.
What could go wrong: This is a post-approval study with a small number of participants (86). The valve may not fit all anatomies, and long-term durability or complications like valve failure or blood clots remain possible.

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 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 REGURGITATION RVOT ANOMALY TETROLOGY OF FALLOT

Contacts and locations

Locations

Mayo Clinic

Rochester, Minnesota, 55902, United States
National Cerebral and Cardiovascular Center

Suita, Osaka, 565-8565, Japan
Nationwide Children's Hospital

Columbus, Ohio, 43215, United States
Primary Children's Hospital

Salt Lake City, Utah, 84113, United States
Ronald Regan UCLA Medical Center

Los Angeles, California, 90095, United States
Seattle Children's Hospital

Seattle, Washington, 98105, United States
Stanford University Medical Center

Palo Alto, California, 94304, United States
Texas Children's Hospital

Houston, Texas, 77030, United States
The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States
The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada
Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada
Yale University

New Haven, Connecticut, 06510, United States

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