Surgical Ablation of AF Efficacy Trial
Recruiting · NCT05434819 · Interventional (participants receive a specific treatment) · Lead sponsor: Population Health Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Surgical Atrial Fibrillation Ablation
What this trial is about
SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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:
- 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
Where it is running
1 location listed.
- Hamilton General Hospital - Hamilton, Ontario, Canada