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Heart valve showdown: which TAVI design saves more lives?

NCT ID NCT05454150

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,960 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

The study population will be comprised of all patients with severe, calcific, symptomatic aortic stenosis eligible to percutaneous transfemoral TAVI with BE or SE-valve according to the investigating center heart team. The inclusion/exclusion criteria are limited and primarily intend to select patient eligible to both BE and SE-valve. This allows for a study cohort whose composition is expected to be close to an all-comers cohort and therefore representative for the standard TAVI population seen in daily practice. Inclusion Criteria: * Symptomatic severe aortic stenosis defined according to the current echocardiography criteria of the European Society of Cardiology guidelines2. * Heart team of the investigating center agrees that the patient is eligible to TAVI with BE-valve SAPIEN 3 (Edwards Lifesciences©) (or further iterations of the same family) OR TAVI with the SE-valve Evolut-R/pro (Medtronic©) (or futher iterations of the same family). * Heart team of the investigating center agrees that TAVI is feasible via percutaneous transfemoral approach. * Written informed consent to the BEST study * Written informed consent to the FRANCE-TAVI registy * All valve anatomy are authorized (bicuspid or tricuspid aortic valve) Exclusion Criteria: * Age \< 18 years old * Patient with legal protection * Non-affiliation to a social security scheme * Pregnancy * Subject participating in another research protocol on TAVI procedure * Patients presenting with an anatomy that is regarded unsuitable for the implantation of one of the two valve types * TAVI through nontransfemoral approach or surgical cutdown * Valve-in-valve procedure (TAVI in TAVI or TAVI in surgical aortic bioprosthesis) * Implantation of Accurate Neo or Accurate Neo2 valve (Boston scientific) * Severe aortic regurgitation (\>3+) * Refusal to participate to FRANCE-TAVI registry

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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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