Heart valve showdown: which TAVI design saves more lives?

NCT ID NCT05454150

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

Summary

This trial compares two types of replacement heart valves used in a procedure called TAVI for people with a narrowed aortic valve. One valve expands with a balloon, the other expands on its own. The study will track about 1,960 patients to see which valve leads to fewer deaths or strokes within 90 days and one year. The goal is to find out if one design is clearly better.

What this could mean

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

Active substance

balloon-expandable valve (Sapien 3/Ultra) or self-expanding valve (Evolut R/Pro)

What this could lead to

If it works, this could show which valve design is safer and more effective for treating aortic stenosis, potentially changing standard practice.

What could go wrong

This is a large but early-stage comparison; results may not show a clear winner, and individual patient factors could still influence outcomes.

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.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis heart valve disorder

As listed by the trial registrant

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

Contacts and locations

Locations

  • AP-HP Hôpitaux Universitaires Henri Mondor

    Créteil, France

  • AP-HP Hôpitaux Universitaires Pitié Salpêtrière

    Paris, France

  • CH Annecy Genevois

    Annecy, France

  • CHU Reims - Hôpitam Robert Debré

    Reims, France

  • CHU de Besançon

    Besançon, France

  • CHU de Bordeaux Hôpital Pellegrin

    Pessac, France

  • CHU de Caen

    Caen, France

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, France

  • CHU de Grenoble

    Grenoble, France

  • CHU de Montpellier

    Montpellier, France

  • CHU de Nantes - Hôpital Laennec

    Saint-Herblain, France

  • CHU de Nîmes

    Nîmes, France

  • CHU de Saint-Etienne

    Saint-Etienne, France

  • CHU de Strasbourg

    Strasbourg, France

  • CHU de Toulouse

    Toulouse, France

  • CHU de Tours

    Tours, France

  • Centre Médico Chirurgical Arnault Tzanck

    Saint-Laurent-du-Var, France

  • Hôpital Privé Saint-Martin

    Caen, France

  • Institut Cardiovasculaire Paris Sud

    Massy, France

  • Institut Mutualiste Montsouris

    Paris, France

  • Médipôle Lyon Villeurbanne

    Villeurbanne, France