Comparative Observational Study of Supra-annular Versus Intra-annular Self-expanding Aortic Valves in Routine Clinical Practice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Trans-catheter Aortic Valve Implantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
We proposed to compare in an observational study procedural success at one month (VARC 3 criteria) and clinical and echographic follow-up at 6 months between 2 self expandable devices in TAVR : the supra annular Evolut device (Medtronic) vs the intra anular NAVITOR device (Abott)
Detailed description
Compared with balloon-expandable valves, self-expandable supra annular devices (Mertronic Evolut) offer superior post-procedural hemodynamics in TAVR and are, therefore, expected to play a growing role in clinical practice particularly in small aortic anatomies . However, the relatively long stent frame of self-expandable valves posed challenges for coronary access after implantation and PPI rates remain higher, despite lower implantation height with the cusp overlap technique The Navitor valves (Abbott Structural Valve) is a new generation intra-annular self-expandable device with tall stent frame but larger stent cells and shorter outer skirt which may be more favorable for future coronary access than the Evolut FX valves, particularly in patients with lower coronary heights . The Navitor platform showed satisfying data in tricuspid anatomy, providing intra-annular leaflets, an innovative sealing cuff, and repositionability .However this platform showed a high rate of PPI that could be related to the need for lower implantation to stabilize the device (first generation) Considering the lack of specific data regarding the compared performance of the 2 plateforms including latest generation devices, we aimed to evaluate procedural success, clinical and hemodynamic results, and conductive disorders between the 2 platforms in an observational real life study
Primary outcome measures
- Device success according to VARC 3 criteria [Time frame: 1 month follow up]
Eligibility criteria
Inclusion criteria
- all patients elligible for TAVR witn a self expandable device
Exclusion criteria
- femoral access not suitable
- valve in valve procedures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- University hopsital — Montpellier
Identifiers
NCT: NCT07506382 · 2025-12-397