Clinical trial Recruiting at 1 site Observational Ages 18 and up

Comparing supra-annular versus intra-annular self-expanding aortic valves in routine TAVR practice

Official title: Comparative Observational Study of Supra-annular Versus Intra-annular Self-expanding Aortic Valves in Routine Clinical Practice

Run by University Hospital, Montpellier · NCT07506382 · Data updated 2026-11-12

This project will try to see if the supra‑annular Evolut valve or the intra‑annular Navitor valve gives better one‑month procedural success and six‑month clinical and echocardiographic results for patients receiving TAVR with self‑expanding devices.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment419 (estimated)
SponsorUniversity Hospital, Montpellier
Academic / other
Locations1 site (Montpellier, Occitanie)
StatusRecruiting
StartedFebruary 10, 2026
Main results expectedFebruary 15, 2028
Study endsMarch 2028
Registry record updatedApril 1, 2026
Trial IDNCT07506382 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults eligible for transfemoral TAVR with a self‑expandable valve who are not undergoing valve‑in‑valve procedures.

Probably not a fit

Patients who need non‑femoral access, are undergoing valve‑in‑valve procedures, or require a balloon‑expandable valve are unlikely to benefit from enrollment in this comparison.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, real‑world comparison of two self‑expanding transcatheter aortic valve platforms—the supra‑annular Evolut (Medtronic) and the intra‑annular Navitor (Abbott)—performed at a single tertiary center. The primary outcome is procedural success at one month using VARC‑3 criteria, with clinical, conduction, and echocardiographic follow‑up at six months to compare hemodynamics, pacemaker rates, and coronary access implications. Eligible patients are those suitable for TAVR with a self‑expandable device via femoral access; valve‑in‑valve procedures and unsuitable femoral access are excluded. The analysis will use routine clinical and imaging data to describe comparative performance in contemporary practice rather than randomize therapy.

Why it matters

Potential benefit: If successful, the comparison could help clinicians choose between Evolut and Navitor platforms to improve short‑term procedural success, hemodynamics, and reduce conduction or coronary access problems.

How similar studies have gone: Prior data show supra‑annular Evolut valves generally deliver superior post‑procedural hemodynamics and Navitor has promising early results but higher pacemaker rates were reported with earlier Navitor experience, and direct head‑to‑head comparisons remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* all patients elligible for TAVR witn a self expandable device

Exclusion Criteria:

* femoral access not suitable
* valve in valve procedures

Where it's running

  • University hopsital
    Montpellier, Occitanie, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.