Status:
RECRUITING
Surgical Ablation of AF Efficacy Trial
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
Hamilton Health Sciences Corporation
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
Atrial fibrillation (AF) affects more than 1% of the general population and is an important risk factor for stroke. AF prevalence increases with age, occurring in 10 to 15% of patients older than 80 y...
Eligibility Criteria
Inclusion
- 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
- 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:
- Heart transplant
- Complex congenital heart surgery
- Sole indication for surgery is ventricular assist device insertion
- Mitral valve repair or replacement
- Tricuspid valve repair or replacement
- Patient resides in a long-term care facility
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT05434819
Start Date
June 1 2023
End Date
December 31 2026
Last Update
March 4 2025
Active Locations (1)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2