Recruiting

Surgical Ablation

Sponsor:

Population Health Research Institute

Code:

NCT05434819

Conditions

Atrial Fibrillation

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgical Atrial Fibrillation Ablation

Study Details

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.

Conditions

Atrial Fibrillation

Heart Failure

Study ID

NCT05434819

Start date

Jun 1, 2023

Status verified date

Feb, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Surgical Atrial Fibrillation Ablation Group

Surgeon will perform left atrial ablation during patient's cardiac surgery procedure.

no intervention: No Surgical Atrial Fibrillation Ablation Group

Surgeon will not perform left atrial ablation during the patient's cardiac surgery procedure.

Interventions

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.

Primary outcome measure

  • Number of hospital readmissions for heart failure over duration of follow-up [ Time Frame: Common termination point for trial (median follow-up of 4 years) ]

Central Contacts and Locations

Central contacts

Richard Whitlock

905-521-2100Richard.Whitlock@phri.ca

SAFE Coordinators

SAFE@phri.ca

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Richard Whitlock, MD PhD FRCSC

905-527-4322richard.whitlock@phri.ca

Principal Investigator:

Richard Whitlock, MD MSc FRCSC

More Information

Sponsor

Population Health Research Institute

Last update posted

Mar 4, 2025

Last verified

Feb, 2025

Keywords

  • Surgical Ablation
  • Cardiac Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2025-03-04.