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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT01561651
Eligibility Criteria:
Inclusion Criteria:
1. Greater than 18 years of age
2. Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass
3. Have a documented history of atrial fibrillation or atrial flutter
4. CHA2DS2-VASc score ≥ 2
5. Have provided informed consent
Exclusion Criteria:
1. Patients undergoing off-pump cardiac surgery
2. Patients undergoing any of the following procedures:
* heart transplant
* complex congenital heart surgery
* sole indication for surgery is ventricular assist device insertion
* previous cardiac surgery requiring opening of the pericardium
* mechanical valve implant
3. Patients who have had a previous placement of a percutaneous left atrial appendage closure device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01561651
Study Brief:
Protocol Section:
NCT01561651