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 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT02737150
Eligibility Criteria:
Inclusion Criteria:
* Severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm²/m²
* Age ≥75 years and/or logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥20% and/or Society of Thoracic Surgeons (STS) risk score ≥10% and/or high risk/contraindication to conventional surgical aortic valve replacement
* Native aortic valve annulus measuring 18-29 mm
* Suitability for transfemoral vascular access
* Written informed consent
Exclusion Criteria:
* Life expectancy \<12 months due to comorbidities
* Cardiogenic shock or hemodynamic instability
* History of or active endocarditis
* Contraindications for transfemoral access
* Active peptic ulcer or upper gastro-intestinal bleeding \<3 months
* Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
* Contraindication for a specific mode of anesthesia as judged by the cardiac anesthesia representative of the Heart Team
* Active infection requiring antibiotic treatment
* Participation in another trial
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02737150
Study Brief:
Protocol Section:
NCT02737150