New heart valve replacement could help thousands avoid Open-Heart surgery

NCT ID NCT07516444

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

Disclaimer Read more

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 TRICUSPID VALVE INSUFFICIENCY are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart valve disorder tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••