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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT04816851
Eligibility Criteria:
Inclusion Criteria:
* Subject with AV disease.
* Documented symptomatic moderate or greater aortic stenosis
* small aortic annulus patients
* A symptomatic aortic insufficiency patient with left ventricular dysfunction or significant left ventricular dilatation.
* Patients with aortic regurgitation caused by: a dilated aortic annulus, conjoined cusp prolapse in bicuspid aortic valves (BAV), single cusp prolapse in tricuspid aortic valve (especially in paediatric population), and aortic valve cusp perforation from endocarditis.
* Concomitant intervention of the aortic root, Concomitant intervention of the aortic arch, Concomitant valve surgery and Concomitant intervention at congenital anomaly.
Exclusion Criteria:
* Patients with previous aortic valve surgery.
* missing informed consent
* Participation in another clinical research.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04816851
Study Brief:
Protocol Section:
NCT04816851