Surgical Ablation of AF Efficacy Trial

NCT05434819 · tracked via the Priya Life Science Canada tracker

Sponsor

Population Health Research Institute

Phase

Not applicable

Started

2023-06-01

Last updated

2025-03-04

Condition(s) studied

Atrial FibrillationHeart Failure

Investigational drug(s) / intervention(s)

Surgical Atrial Fibrillation Ablation

Surgical 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Number of hospital readmissions for heart failure over duration of follow-up — Common termination point for trial (median follow-up of 4 years)
Total number of hospital readmissions for heart failure.

Trial sites (1)

Facility	City	Region	Status
Hamilton General Hospital	Hamilton	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05434819 on ClinicalTrials.gov ↗ ← All trials in Canada