Heart valve showdown: intermediate sizing may reduce complications in aortic stenosis

NCT ID NCT07689279

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial tests whether a newer balloon-expandable heart valve with intermediate sizes (Myval) is as safe as a standard self-expanding valve (Evolut) in people with severe aortic stenosis whose valve measurements fall in a 'borderline' range. About 600 participants will be randomly assigned to receive one of the two valves during a routine transcatheter aortic valve replacement (TAVI). The study will track safety events like death, stroke, bleeding, and need for a pacemaker within 30 days, and follow patients for up to 5 years to see how well the valve works over time.

What this could mean

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

Active substance
Transcatheter heart valve (Myval or Evolut series)
What this could lead to
If the Myval valve with intermediate sizes proves safer or equally safe, it could offer a better fit for people with borderline anatomy, reducing complications.
What could go wrong
This is a phase 4 trial comparing existing devices, not a new cure. The benefit may be small, and complications like bleeding or need for a pacemaker are still possible.

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.

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