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:
NCT03495050
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years.
2. NYHA≥2 and/or syncope and/or angina.
3. Patient judged by the Heart Team as indicated for TAVI.
4. Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.
5. Estimated life-expectancy\>1 year.
Exclusion Criteria:
1. Age \<18 years
2. Asymptomatic patients
3. Estimated life expectancy\<1 year
4. Pure aortic regurgitation.
5. LVEF\<20%
6. No baseline MSCT evaluation.
7. Unsuitable aortic root anatomy for Evolut Pro or XL.
8. Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03495050
Study Brief:
Protocol Section:
NCT03495050