Heart valve showdown: which TAVI design saves more lives?

NCT ID NCT05454150

Ongoing Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

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.

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 heart valve disorder

As listed by the trial registrant

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

AORTIC VALVE STENOSIS

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

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