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 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 12:23 AM
NCT ID:
NCT04639258
Eligibility Criteria:
Key Inclusion Criteria:
* Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm\^2, or aortic valve area index ≤ 0.6 cm\^2/m\^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec
* Subject denies symptoms attributable to aortic stenosis, including but not limited to:
* Dyspnea on rest or exertion
* Angina
* Syncope in the absence of another identifiable cause
* Fatigue
* Left Ventricular Ejection Fraction (LVEF) \>50%
Key Exclusion Criteria:
* Age \<65 years
* Class I indication for cardiac surgery
* Bicuspid, unicuspid, or quadricuspid aortic valve
* In need of and suitable for coronary revascularization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04639258
Study Brief:
Protocol Section:
NCT04639258