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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT02504632
Eligibility Criteria:
Inclusion Criteria:
* Test group
* Severe symptomatic AS (Aortic valve area \< 0,6 cm2/m2 SC), deemed, after multidisciplinary heart team evaluation, contra-indicated or at high risk for surgery and suitable for TF TAVI with a MCV prosthesis.
* Aspirin treatment (75-160 mg/d for at least one week)
* Control group
* Stable coronary artery disease, unscathed of AS
* Aspirin treatment (75-160 mg/d for at least one week)
Exclusion Criteria:
* Test group:
* Acute coronary syndrome 1 month before inclusion
* Any co-morbidity limiting life-expectancy \< 1 year
* Terminal chronic kidney disease requiring hemodialysis thrombocytopenia \<100 G/L, anemia (Hb \< 10 g/dl)
* Treatment by another antiplatelet agent within 10 days before the procedure
* Control group:
* Acute coronary syndrome 1 month before inclusion
* Any co-morbidity limiting life-expectancy \< 1 year
* Terminal chronic kidney disease requiring hemodialysis
* Thrombocytopenia \<100 G/L
* Treatment by another antiplatelet agent within 10 days before the procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02504632
Study Brief:
Protocol Section:
NCT02504632