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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 419 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, Occitanie) |
| Status | Recruiting |
| Started | February 10, 2026 |
| Main results expected | February 15, 2028 |
| Study ends | March 2028 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT07506382 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
- Study coordinator: Florence LECLERCQ, MD
- Email: f-leclercq@chu-montpellier.fr
- Phone: +33467336212
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pre-emptive LAVA-ECMO support for complex, high-risk TAVR
The team will try pre-emptive left atrial veno-arterial ECMO to stabilize adults with severe aortic stenosis undergoing complex, high-risk TAVR who are unstable or at risk of instability.
-
Islet re-transplantation after prior graft failure in adults with type 1 diabetes
This study looks at whether giving another islet transplant after a prior failed graft helps adults with type 1 diabetes who have severe swings in blood sugar.
-
Tissue models of systemic sclerosis using patient-derived iPSCs
Researchers will create iPSC lines from people with systemic sclerosis, their healthy relatives, and test them across several cell types to see how the disease affects tissues in the lab.
-
L-dopa treatment for a CTNNB1-related neurodevelopmental disorder in children
This study tests whether L-dopa can help children with a CTNNB1-related neurodevelopmental disorder who have dystonia.
-
Exploratory look at brain blood flow and metabolism before and after removing unruptured AVMs
This study tests brain perfusion and metabolism with PET imaging and neuropsychological tests in adults before and six months after surgical treatment for unruptured brain AVMs.
-
Immun4Cure Cohort of Autoimmune Diseases
A long-term, 500-person database and biobank is being built to study autoimmune diseases like RA, SLE, and scleroderma, plus healthy adults, using deep profiling and regular follow-ups over five years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.