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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT01982032
Eligibility Criteria:
Inclusion criteria
In order to be eligible to participate in this study, subjects must meet all of the following criteria:
* Patient is ≥18 years of age and diagnosed with severe symptomatic aortic stenosis, judged inoperable or at high surgical risk (EuroSCORE \> 15% or other criteria that make surgery high risk by a consensus among cardiologists and cardiac surgeons in the heart team) and deemed eligible for transfemoral-TAVI.
* Aortic annulus diameter ≥ 18 and ≤ 29 mm as assessed with MSCT.
* No contraindications to study requirements such as MRI or TEE.
Exclusion criteria
* Patients unable or unwilling to give informed consent.
* Patients who are excluded from this study because of the size of their aortic annulus diameter.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01982032
Study Brief:
Protocol Section:
NCT01982032