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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT05714293
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years;
* Aortic valve stenosis or insufficiency with indication for elective aortic valve replacement with a bioprosthesis;
* Possible concomitant coronary artery disease with indication for surgical or percutaneous revascularization;
* CT imaging of the thorax with iodinated contrast agent carried out before surgery;
* Signed informed consent, inclusive of release of medical information.
Exclusion Criteria:
* Aortic valve replacement in bicuspid valve 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 at time of screening;
* Allergy or hypersensitivity to iodinated contrast agent;
* End-stage renal disease on dialysis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05714293
Study Brief:
Protocol Section:
NCT05714293