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.
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
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University of Galway
Galway, Ireland
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Other studies related to the condition(s) this trial covers.
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