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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT07021612
Eligibility Criteria:
Inclusion Criteria:
1. receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH
2. with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
3. Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)
4. Capable of providing informed consent
Exclusion Criteria:
1. Evidence of intracardiac mass, thrombus or vegetation
2. Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
3. Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
4. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
5. Chronic Kidney Disease with eGFR \<30 ml/min/1.73m2.
6. Cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device
7. Contraindicated for CT or MRI assessment
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07021612
Study Brief:
Protocol Section:
NCT07021612