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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT03600935
Eligibility Criteria:
Inclusion Criteria:
Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding transcatheter heart valve
1. Considered at increased surgical risk by the Multidisciplinary Heart Team
2. Informed written consent
Exclusion Criteria:
1. Non-cardiovascular co-morbidity reducing life expectancy to \<3 years
2. Any factor precluding 1 year follow-up
3. Inadequate CT image acquisition to perform area-based annular CT sizing, exclude adverse root features, and determine a coaxial valve deployment angle (CT is not required for valve-in-valve procedures)
4. Predicted inability to perform uncomplicated percutaneous vascular access and closure
5. Illiofemoral diameter \<6 mm (for 23 and 25 mm valves) and \<6.5 mm (for 27 and 29 mm valves) measured at or below the femoral head
6. Surgical prosthesis \<23 mm (labelled size) for valve-in-valve procedure
7. In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons)
8. Language barriers (inability to understand peri-procedural and discharge instructions)
9. Insufficient social support post procedure to allow next day discharge
10. Airway unfavourable for emergent intubation
11. Inability to lay supine without conscious sedation or general anaesthetic
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03600935
Study Brief:
Protocol Section:
NCT03600935