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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT04694859
Eligibility Criteria:
Inclusion Criteria:
* severe symptomatic aortic valve stenosis
* high risk or patients deemed amenable for TAVI by a multidisciplinary team
* signed informed consent to participate in the study
Exclusion Criteria:
* inadequate annulus size (\<18 mm, \>29 mm)
* left ventricle thrombus
* active endocarditis
* high risk of coronary ostium obstruction
* plaques with mobile thrombi in the ascending aorta, or arch
* hemodynamic instability
* estimated life expectancy \<1 year
* comorbidity suggesting lack of improvement of quality of life
* other situations adjudicated by the local HeartTeam
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04694859
Study Brief:
Protocol Section:
NCT04694859