RecruitingNot ApplicableNCT05434819

Surgical Ablation of AF Efficacy Trial

Sponsor

Population Health Research Institute

Enrollment

2,000 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure Atrial Fibrillation

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria10

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

Interventions

PROCEDURESurgical Atrial Fibrillation Ablation

Surgeon will preform surgical atrial fibrillation ablation using either cryoablation or bipolar radiofrequency clamps including 2 layers of atrium or vein, a minimum of 2 burns per clamping with at least 3 lines in the ablation group. Cavo-tricuspid isthmus and mitral lines will be allowed.