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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT05983458
Eligibility Criteria:
Inclusion Criteria:
1. Age \>=18 and =\< 83 years
2. Normal PR interval at 12-lead electrocardiogram (ECG)
3. No evidence of Right bundle branch block (RBBB) or high-degree Atrioventricular Block ( AV) blocks at 12-lead ECG
4. eGFR \> 50 ml/min/1.73 m2
5. Ilio-femoral anatomy compatible with transfemoral transcatheter aortic valve implantation (TAVI)
Exclusion Criteria:
1. Inability to provide informed consent
2. Not suitable anatomy for transfemoral access
3. Need for general anaesthesia (e.g. hemodynamic instability)
4. Bicuspid aortic valve anatomy
5. Severely impaired left ventricular ejection fraction (LVEF \<35%)
6. At least moderate mitral regurgitation
7. Non-cardiac illness with a life expectancy of less than 1 year
8. Currently participating in another trial before reaching first endpoint.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
83 Years
Study:
NCT05983458
Study Brief:
Protocol Section:
NCT05983458