Clinical trial NCT05434819: Surgical Ablation of AF Efficacy Trial
Official title: Surgical Ablation of AF Efficacy Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Heart Failure
Keywords: Surgical Ablation
Cardiac Surgery
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2022-06-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of hospital readmissions for heart failure over duration of follow-up
timeFrame: Common termination point for trial (median follow-up of 4 years)
Secondary outcomes:
measure: Number of Ischemic stroke or systemic arterial embolism events over duration of follow up
timeFrame: Common termination point for trial (median follow-up of 4 years)
measure: Length of ICU stay
timeFrame: 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)
measure: Length of hospital stay
timeFrame: 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)
measure: Freedom from recurrence of atrial tachyarrhythmia
timeFrame: 1 year post-operatively
measure: Number of days free from admission to healthcare facility or presentation to the emergency department for heart failure
timeFrame: Common termination point for trial (median follow-up of 4 years)
measure: All-cause mortality
timeFrame: Common termination point for trial (median follow-up of 4 years)
measure: Cardiovascular mortality
timeFrame: Common termination point for trial (median follow-up of 4 years)
measure: Antiarrhythmic drug use
timeFrame: Beyond 6 weeks until common termination point for trial (median follow-up of 4 years)
measure: Number of patients undergoing atrial fibrillation ablation
timeFrame: 90 days post- study surgery until common termination point for trial (median follow-up of 4 years)
measure: Quality of Life - atrial fibrillation specific
timeFrame: At 1 year, and at common termination point for trial (median follow-up of 4 years)
measure: Quality of Life - heart failure specific
timeFrame: At 1 year, and at common termination point for trial (median follow-up of 4 years)
measure: Quality of Life - General
timeFrame: At 1 year, and at common termination point for trial (median follow-up of 4 years)
Other outcomes:
measure: Number of Ischemic stroke and systemic arterial embolism
timeFrame: Up to 30 days post-operatively
measure: Number of patients requiring permanent pacemaker implantation
timeFrame: Up to 1 year post-operatively
measure: Volume of chest tube output
timeFrame: Up to 24 hours post-operatively
measure: Re-operation for bleeding
timeFrame: From date of study intervention surgery completion to date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
measure: All-cause mortality
timeFrame: Prior to discharge or within 30 days post-operatively (whichever occurs first)
measure: Post-operative major bleeding
timeFrame: <48 hours after surgery
measure: Number of patients with pulmonary vein stenosis
timeFrame: At 1 year, and at common termination point for trial (median follow-up of 4 years)
measure: Number of patients with stiff left atrium syndrome
timeFrame: At 1 year, and at common termination point for trial (median follow-up of 4 years)
measure: Number of patients with esophageal to atrial fistula
timeFrame: At 1 year, and at common termination point for trial (median follow-up of 4 years)
measure: Health economic analysis of surgical atrial fibrillation
timeFrame: At 1 year, and at common termination point (median follow-up of 4 years)
measure: Health economic analysis of surgical atrial fibrillation
timeFrame: At 1 year, and at common termination point (median follow-up of 4 years)
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Richard Whitlock
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: Emilie Belley-Côté
role: PRINCIPAL_INVESTIGATOR
References: