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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT01363895
Eligibility Criteria:
Inclusion Criteria:
1. Patients with oligosymptomatic AF eligible for both interventions (CA and LAA closure device implantation).
2. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
3. In women with childbearing potential a negative pregnancy test is mandatory.
Exclusion Criteria:
1. Left atrial thrombus
2. Other indication than AF for oral anticoagulation (valve prosthesis, pulmonary embolism, recurrent vein thrombosis)
3. Contraindication for oral anticoagulation
4. Severe valvular heart disease
5. Severe left ventricular systolic function (ejection fraction\<30%)
6. Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
7. Pregnancy (present, suspected or planned) or positive pregnancy test.
8. Patient's inability to fully cooperate with the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01363895
Study Brief:
Protocol Section:
NCT01363895