Surgical Ablation of AF Efficacy Trial

NCT05434819 | Recruiting DMC

• 1 other identifier: SAFEV1.0
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Keywords

Surgical Ablation; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Number of hospital readmissions for heart failure over duration of follow-up

  Total number of hospital readmissions for heart failure.

  Common termination point for trial (median follow-up of 4 years)

Secondary Outcomes (12)

• Number of Ischemic stroke or systemic arterial embolism events over duration of follow up

  Common termination point for trial (median follow-up of 4 years)

• Length of ICU stay

  From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)

• Length of hospital stay

  From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)

• Freedom from recurrence of atrial tachyarrhythmia

  1 year post-operatively

• Number of days free from admission to healthcare facility or presentation to the emergency department for heart failure

  Common termination point for trial (median follow-up of 4 years)

Other Outcomes (11)

• Number of Ischemic stroke and systemic arterial embolism

  Up to 30 days post-operatively

• Number of patients requiring permanent pacemaker implantation

  Up to 1 year post-operatively

• Volume of chest tube output

  Up to 24 hours post-operatively

Study Arms (2)

Surgical Atrial Fibrillation Ablation Group

EXPERIMENTAL

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

Procedure: Surgical Atrial Fibrillation Ablation

No Surgical Atrial Fibrillation Ablation Group

NO INTERVENTION

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

Interventions

Surgical Atrial Fibrillation Ablation 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.

Surgical Atrial Fibrillation Ablation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Whitlock

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Emilie Belley-Côté

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Whitlock

CONTACT

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

SAFE Coordinators

CONTACT

SAFE@phri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding to allocation will be maintained for all parties, excluding the operating surgeon and necessary operating room personnel.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Each patient will be assigned in a blinded fashion to one of two groups (atrial fibrillation ablation or no atrial fibrillation ablation) in a 1:1 ratio.

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: June 28, 2022
• Study Start: June 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

CA (1)