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Comparing two types of heart valves for treating aortic valve stenosis

Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis

Not applicable Interventional University Hospital, Lille · NCT05454150

This study is testing whether two different types of heart valves can help people with aortic valve stenosis feel better and have similar results after treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1862 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Lille Academic / other
Locations21 sites (Besançon and 20 other locations)
Trial IDNCT05454150 on ClinicalTrials.gov

What this trial studies

This study aims to compare the clinical outcomes of balloon-expandable and self-expanding transcatheter heart valves in patients with symptomatic aortic valve stenosis. It will include patients who are eligible for percutaneous transfemoral transcatheter aortic valve implantation (TAVI) with either valve type. The goal is to determine if these two different valve designs achieve similar or different results in treating this condition, addressing a significant gap in current clinical knowledge. By conducting this large randomized study, the researchers hope to provide clarity on the effectiveness of these devices in everyday practice.

Who should consider this trial

Good fit: Ideal candidates are patients with severe, symptomatic aortic stenosis who are eligible for TAVI with either a balloon-expandable or self-expanding valve.

Not a fit: Patients with asymptomatic aortic stenosis or those not eligible for TAVI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify the most effective heart valve design for patients with aortic valve stenosis, potentially improving treatment outcomes.

How similar studies have performed: While there have been studies comparing TAVI to surgical options, this specific comparison of balloon-expandable versus self-expanding valves is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Besançon and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Aortic Valve StenosisAortic valve stenosisTAVIBalloon-expandable transcatheter heart valveSelf-expanding transcatheter heart valve,heart valve disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.