Heart valve showdown: which TAVI device is better?

NCT ID NCT06470022

Recruiting now Disease control Sponsor: Christian Juhl Terkelsen Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial compares two different TAVI devices (Evolut FX and Sapien 3 Ultra Resilia) used to replace a narrowed heart valve in people with aortic stenosis. About 1,346 patients will be randomly assigned to get one device or the other. Researchers will track deaths, strokes, valve leaks, and device wear over one year, with follow-up up to 10 years.

What this could mean

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

Active substance: TAVI devices (Medtronic Evolut FX and Edwards Sapien 3 Ultra Resilia)
What this could lead to: If one device proves superior, it could become the preferred option for treating aortic stenosis, potentially reducing complications and improving outcomes.
What could go wrong: This is a head-to-head device comparison, not a new treatment. Both devices are already approved, so the trial may only show small differences. Results are preliminary until long-term follow-up is complete.

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.

aortic valve stenosis

As listed by the trial registrant

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

AORTIC STENOSIS

Contacts and locations

Locations

Department of cardiology, Aarhus University Hospital
RECRUITING

Aarhus, 8200, Denmark

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