Comparing supra-annular versus intra-annular self-expanding aortic valves in routine TAVR practice
Comparative Observational Study of Supra-annular Versus Intra-annular Self-expanding Aortic Valves in Routine Clinical Practice
University Hospital, Montpellier · NCT07506382
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 type | Observational |
|---|---|
| Enrollment | 419 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 1 site (Montpellier, Occitanie) |
| Trial ID | NCT07506382 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults eligible for transfemoral TAVR with a self‑expandable valve who are not undergoing valve‑in‑valve procedures.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Montpellier, Occitanie
- University hopsital — Montpellier, Occitanie, France (RECRUITING)
Study contacts
- Study coordinator: Florence LECLERCQ, MD
- Email: f-leclercq@chu-montpellier.fr
- Phone: +33467336212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Trans-catheter Aortic Valve Implantation, self expandable devices, intra annular design, supra annular design, procedural success, hemodynamics