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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT05721820
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 y.o.;
* The patient has undergone a previous TAVI;
* The Transcatheter Heart Valve (THV) implanted for TAVI procedure is a cumbersome and long self-expandable device (e.g. CoreValve, CoreValve Evolut R, Portico valve);
* The patient has already undergone a post-TAVI cardiac-gated CT-scan with contrast medium which includes the aortic arch (generally for other reasons such as participation into a clinical study with a previous Ethical Committee approval; residual aortic regurgitation assessment for Valve-in-Valve evaluation; TAVI complication assessment)
Exclusion Criteria:
* Age\<18 y.o.;
* The Transcatheter Heart Valve (THV) implanted for TAVI procedure is a low-profile balloon-expandable device (e.g. Sapien);
* The patient has already undergone a post-TAVI cardiac-gated CT-scan with contrast medium which DOES NOT include the aortic arch.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05721820
Study Brief:
Protocol Section:
NCT05721820