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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT06818435
Eligibility Criteria:
Inclusion Criteria:
1. Patient over the age of 18 years with symptomatic aortic stenosis (severe AS) who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.
2. Patient has provided written informed consent as approved by the Ethics Committee (EC)
3. Patient is willing to undergo all registry procedures and follow-up requirements
Exclusion Criteria:
1. Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
2. Ongoing infective endocarditis or any similar infection.
3. Pregnant or lactating females.
4. Liver failure (Child-Pugh Class B or C)
5. Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved.
6. Any condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06818435
Study Brief:
Protocol Section:
NCT06818435