New heart valve trial aims to improve Second-Time valve replacements

NCT ID NCT07524595

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

Summary

This trial is for people whose surgically implanted aortic heart valve has stopped working properly. It compares two types of replacement valves placed through a tube in the leg (TAVI): a newer self-expanding valve (Hydra) versus standard balloon-expandable valves (Sapien or MyVal). The goal is to see which valve allows better blood flow through the heart. About 111 participants will be randomly assigned to receive one of the valve types.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

Hydra THV Series (self-expanding valve) and Sapien/MyVal THV Series (balloon-expandable valves)

What this could lead to

If successful, this trial could show that the Hydra valve provides better blood flow than current balloon-expandable valves for patients needing a second valve replacement.

What could go wrong

This is a relatively small, early-stage trial (111 patients) comparing devices, not testing a new cure. Results may not apply to all patients, and there are standard risks of TAVI procedures like bleeding or valve issues.

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 VALVE-IN-VALVE PROCEDURES are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Aortic Valve Disease aortic valve disease 2 aortic valve disorder

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Galway

    Galway, Ireland

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