Surgical Ablation of AF Efficacy Trial

NCT ID: NCT05434819

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

Atrial fibrillation (AF) affects more than 1% of the general population and is an important risk factor for stroke. AF prevalence increases with age, occurring in 10 to 15% of patients older than 80 years of age, which is important with the aging population. Of patients undergoing cardiac surgery, 10.8% have a history of AF. AF is believed to cause the left atrium to dilate and lose its transport function. AF significantly increases the risk of ischemic stroke of cardioembolic origin, but is also associated with heart failure and impairs quality of life. Although the causal relationship between the 2 clinical entities has not been fully elucidated, AF is believed to cause heart failure via several mechanisms.

Ablation of AF is the application of scars to the atrial tissue to disrupt faulty electrical signals that cause the arrhythmia. If surgical ablation of AF yields a benefit similar to catheter-based AF ablation, thousands of people undergoing cardiac surgery could benefit from this procedure each year. SAFE will be a landmark trial in cardiac surgery, definitely establishing surgical AF ablation's impact on cardiovascular outcomes. Cardiac surgery is the optimal setting to establish whether maintenance of sinus rhythm through AF ablation yields clinical benefit, and is a setting where sham-control is possible. This will not only provide evidence for the cardiac surgical patients but will bolster the evidence for ablation (catheter or stand-alone surgical) in other AF patients.

The intervention under investigation is concomitant surgical AF ablation which is compared to no surgical AF ablation. The primary outcome is hospital readmissions with heart failure during 4 years of follow-up. This study will enroll 2000 patients from 50 centres, globally. Patients will be followed at hospital discharge, 4 to 6 weeks after surgery, 6 months after surgery, and then at 6-month intervals until the final follow-up visit, for a median follow-up for 4 years.

Conditions

Atrial Fibrillation; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Surgical Atrial Fibrillation Ablation Group

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

Group Type: EXPERIMENTAL

Surgical Atrial Fibrillation Ablation

Intervention Type: PROCEDURE

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.

No Surgical Atrial Fibrillation Ablation Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Richard Whitlock

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Whitlock

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Emilie Belley-Côté

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Richard Whitlock

Role: CONTACT

Richard.Whitlock@phri.ca

905-521-2100

SAFE Coordinators

Role: CONTACT

SAFE@phri.ca

Facility Contacts

Richard Whitlock, MD PhD FRCSC

Role: primary

richard.whitlock@phri.ca

905-527-4322 ext. 40306

Other Identifiers

SAFEV1.0

Identifier Type: -

Identifier Source: org_study_id