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 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT05708118
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Bicuspid aortic valve stenosis treated with surgical or transcatheter aortic valve replacement;
* Concomitant ascending aorta aneurysm, with no indication to surgical treatment at the time of intervention;
* Patients with indication to follow-up Chest CT angiography Scan.
* Signed informed consent, inclusive of release of medical information.
Exclusion Criteria:
* Aortic valve replacement in tricuspid valves or bicuspid insufficient valves or endocarditis;
* Aortic valve replacement associated with surgery of ascending aorta/aortic root;
* Aortic valve replacement associated with other cardiac valve surgery;
* Previous cardiac surgery of any kind;
* Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgment of the investigator;
* Participation in another clinical trial that could interfere with the endpoints of this study;
* Pregnant or breastfeeding at time of screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05708118
Study Brief:
Protocol Section:
NCT05708118