Left Atrial Appendage Occlusion Study II "LAAOSII"


Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Adult patients undergoing any cardiac surgical procedure with the use of cardiopulmonary bypass
- A history of ECG-documented atrial fibrillation with prior stroke or TIA, or at least two of the following risk factors:
- age => 65 years
- hypertension
- diabetes mellitus, or
- heart failure/left ventricular ejection fraction < 50%

Exclusion Criteria

- Patients in whom surgical AF ablation (MAZE or otherwise) is planned
- Planned "off-pump" surgery
- Planned implantation of a mechanical valve
- Heart transplant, complex congenital heart surgery, and ventricular assist device insertion, reoperation