| NCT ID | NCT05434819 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Population Health Research Institute |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-09-30 |
Trial Parameters
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Brief Summary
SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years; * Undergoing a clinically indicated cardiac surgical procedure: CABG, AVR, ascending aorta replacement, or combinations thereof; * Documented history of paroxysmal or persistent AF * Provide informed consent Exclusion Criteria: * Dominant atrial arrhythmia is atrial flutter; * Documented left atrial diameter ≥ 6 cm; * Previous cardiac surgery requiring opening of the pericardium; * Patients undergoing any of the following procedures: 1. Heart transplant 2. Complex congenital heart surgery 3. Sole indication for surgery is ventricular assist device insertion 4. Mitral valve repair or replacement 5. Tricuspid valve repair or replacement * Patient resides in a long-term care facility
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