Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT05454150
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05454150
Study Brief:
Protocol Section:
NCT05454150