New heart valve replacement could help thousands avoid Open-Heart surgery
NCT ID NCT07516444
First seen Jun 27, 2026 · Last updated Aug 17, 2026 · Updated 1 time
Summary
This study tests a new device called the VDyne System, which is placed inside the heart through a tube in a blood vessel to replace a leaky tricuspid valve. The trial will include 730 people with severe symptoms who have not improved with medication. Researchers will compare the VDyne device to another approved device to see which is safer and more effective at improving quality of life and reducing heart failure.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- VDyne transcatheter tricuspid valve replacement system
- What this could lead to
- If successful, this could offer a less invasive treatment option for people with severe tricuspid regurgitation, potentially reducing symptoms and hospitalizations.
- What could go wrong
- This is an early pivotal trial, and the device may not work as well as expected or could cause serious complications like bleeding, stroke, or kidney injury. Long-term benefits are not yet proven.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Minneapolis Heart Institute Foundation
RECRUITINGMinneapolis, Minnesota, 55407, United States
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