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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT03488420
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients aged ≥ 18 years at baseline (signing of consent);
2. Willing and able to provide written informed consent;
3. Patient diagnosed or confirmed with AF and/or AFL within the last 12 months of signed consent form;
4. Patient with VHD confirmed by echocardiography within the last 36 months of signed consent form except for mitral stenosis that must be confirmed within the last 12 months;
5. Patient at risk for stroke in whom a long term oral anticoagulation is indicated and who are prescribed edoxaban.
Exclusion Criteria:
1. Patients with AF and/or AFL secondary to reversible cause;
2. Patients with a mechanical heart valve or rheumatic mitral stenosis, or moderate and severe non rheumatic mitral stenosis;
3. Patients planned to have an intervention for valvular heart disease in the next 12 months;
4. Pregnant or breastfeeding women.
5. Short term anticoagulation post cardioversion or ablation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03488420
Study Brief:
Protocol Section:
NCT03488420