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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07477002
Eligibility Criteria:
Inclusion Criteria:
* Severe AS
* AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board
* Anatomical feasibility to receive a balloon-expandable TAVI
* Age 65 years or older
* Subject or guardian agrees to all provisions of the protocol, including the possibility of randomization to the control group and returning for all required post-procedure follow up visits, and has provided written informed consent
Exclusion Criteria:
* Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated)
* Active infections requiring current antibiotic therapy
* Bicuspid aortic valve anatomy
* Pregnant or planning pregnancy within next 12 months
* Severe calcification of the aortic annulus protruding in the left ventricular outflow tract (predisposing for annular rupture)
* Significant coronary artery disease with substantial risk of hemodynamic instability during rapid ventricular pacing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07477002
Study Brief:
Protocol Section:
NCT07477002