New heart valve could spare congenital patients from repeat surgeries
NCT ID NCT04860765
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new heart valve, called the SAPIEN 3, in 150 people with congenital heart defects whose existing heart valves are not working properly. The valve is placed using a thin tube (catheter) through a blood vessel, avoiding open-heart surgery. The goal is to see if the valve works well and improves blood flow from the heart to the lungs.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
SAPIEN 3 Transcatheter Heart Valve (a replacement heart valve delivered through a catheter)
What this could lead to
If successful, this could offer a less invasive way to replace a faulty heart valve in people with congenital heart disease, potentially avoiding repeat open-heart surgeries.
What could go wrong
This is a post-approval study, so the device is already in use, but long-term outcomes are still being tracked. Risks include blood clots, infection, or the valve not working as well as hoped.
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 PULMONARY VALVE INSUFFICIENCY 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
-
Advocate Childrens Hospital
Oak Lawn, Illinois, 60453, United States
-
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
-
Cedars Sinai
Los Angeles, California, 90048, United States
-
Children's Health Dallas
Dallas, Texas, 75235, United States
-
Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
-
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
-
Cincinatti Children's Hospital
Cincinnati, Ohio, 45229, United States
-
Columbia University Medical Center/NYPH
New York, New York, 10032, United States
-
Dell Children's
Austin, Texas, 78723, United States
-
Duke University
Durham, North Carolina, 27710, United States
-
Minneapolis Heart
Minneapolis, Minnesota, 55407, United States
-
Mount Sinai
New York, New York, 10029, United States
-
Nationwide Children's Hospital
Columbus, Ohio, 43215, United States
-
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
-
Primary Children's
Salt Lake City, Utah, 84108, United States
-
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
-
University of Alabama
Birmingham, Alabama, 35487, United States
-
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 19146, United States
-
University of Virginia
Charlottesville, Virginia, 22908, United States