New No-Scalpel heart valve offers hope for leaky hearts
NCT ID NCT02979587
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.
Disclaimer
Read more
Show less
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for CONGENITAL HEART DISEASE are added.
By submitting, you agree to our Terms of use
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.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
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