Surgical ablation for treating atrial fibrillation during heart surgery
Surgical Ablation of AF Efficacy Trial
This study is testing if a surgical procedure to treat atrial fibrillation during heart surgery can help patients have better heart health and lower their chances of stroke and heart failure compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Population Health Research Institute Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT05434819 on ClinicalTrials.gov |
What this trial studies
The SAFE trial is an international multicenter randomized controlled trial investigating the efficacy of surgical ablation for atrial fibrillation (AF) in patients undergoing cardiac surgery. It aims to determine whether surgical ablation can improve cardiovascular outcomes by maintaining sinus rhythm in patients with paroxysmal or persistent AF. The trial will compare outcomes between patients receiving surgical ablation and those receiving standard care, with a focus on the potential benefits of this intervention in reducing the risk of stroke and heart failure. This landmark trial seeks to provide robust evidence on the impact of surgical AF ablation in the context of cardiac surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a documented history of paroxysmal or persistent atrial fibrillation and are scheduled for clinically indicated cardiac surgery.
Not a fit: Patients with dominant atrial flutter, significant left atrial enlargement, or those undergoing specific cardiac procedures unrelated to AF may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could significantly improve the management of atrial fibrillation in patients undergoing cardiac surgery, potentially reducing the risk of stroke and heart failure.
How similar studies have performed: Previous studies have shown promising results for catheter-based AF ablation, suggesting that surgical ablation may also yield beneficial outcomes, although this specific approach is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamilton, Ontario
- Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Richard Whitlock — Population Health Research Institute
- Study coordinator: Richard Whitlock
- Email: Richard.Whitlock@phri.ca
- Phone: 905-521-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.