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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT01645202
Eligibility Criteria:
Inclusion Criteria:
1. Severe aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm2/m2
2. Presence of clinical symptoms defined as New York Heart Association (NYHA) functional class ≥ 2
3. Age \> 75 years and/or Logistic EuroSCORE ≥ 20% and/or STS risk score ≥ 10% and/or contraindication to conventional surgical aortic valve replacement (porcelain aorta, previous chest radiation, chest deformation)
4. Native aortic valve annulus measuring 20-25 mm
5. Patients must be suitable for a transfemoral vascular access
6. The patient signing a written informed consent prior to intervention
Exclusion Criteria:
1. Life expectancy \< 12 months due to co-morbid conditions
2. Native aortic valve annulus \< 20 mm and \> 25 mm (this could be amended if further valve sizes for the transfemoral approach become available for both prostheses during the study period)
3. Pre-existing aortic bioprosthesis
4. Cardiogenic shock or hemodynamic instability
5. History of, or active endocarditis
6. Contraindications for a transfemoral access
7. Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
8. Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
9. Active infection requiring antibiotic treatment
10. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 3 months post-enrolment
11. Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Study:
NCT01645202
Study Brief:
Protocol Section:
NCT01645202