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:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT05036018
Eligibility Criteria:
Inclusion Criteria:
* Severe symptomatic aortic valve stenosis (AVA ≤1 cm² or 0.6 cm²/m²) with indication for transcatheter aortic valve implantation according to heart team consensus
* Perimeter-derived native aortic valve annulus diameter measuring 21-27 mm
* Heart team consensus that the patient is anatomically suitable for both device types
* Suitability for transfemoral vascular access
* Written informed consent
Exclusion Criteria:
* Life expectancy \<12 months due to comorbidities
* Native aortic valve annulus \<21 mm and \>27 mm
* Bicuspid aortic valve
* Cardiogenic shock or hemodynamic instability
* Active endocarditis
* Contraindications for transfemoral access
* Active peptic ulcer or upper gastro-intestinal bleeding \<2 weeks
* Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
* Contraindication for a specific treatment strategy (minimalist approach vs. standard of care) as judged by the Heart Team
* Clear patient-specific clinical or anatomic reasons to prefer one treatment strategy or valve type over the other
* Active infection requiring antibiotic treatment
* Age \<18 years
* Participation in another interventional trial where the primary endpoint has not been reached
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05036018
Study Brief:
Protocol Section:
NCT05036018