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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT01642134
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
2. Patients with symptomatic degenerative severe aortic stenosis rejected for conventional surgical aortic valve replacement due to unacceptably high risk and accepted for TAVI procedure
3. Signed informed consent.
4. Patients who are not participating in any other clinical trial or research study.
Exclusion Criteria:
1. Patients under oral anticoagulation treatment
2. Patients who can not undergo MRI study
3. Recent stroke \< 14 days prior, revascularized coronary artery disease or life expectancy \< 12 months
4. Patients with proven allergy to aspirin, clopidogrel or acenocoumarol
5. Patients that after TAVI procedure can not undergo a regimen of dual antiplatelet therapy or oral anticoagulation for 3 months due to any new post-TAVI medical indication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01642134
Study Brief:
Protocol Section:
NCT01642134