SAFE
Research type
Research Study
Full title
Surgical Ablation of Atrial Fibrillation Efficacy Trial
IRAS ID
331460
Contact name
Prakash P Punjabi
Contact email
Sponsor organisation
Population Health Research Institute
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Atrial fibrillation (AF), a health condition that causes the heart’s upper chambers (the atria) to expand and lose transport function, affects more than 1% of Canadians. This condition is more common in older patients, affecting 10 to 15% of Canadians older than 80 years. AF significantly increases the risk of ischemic stroke—a type of stroke caused by blood clots blocking blood supply to parts of the brain—heart failure and impairs quality of life. Medical management for patients with AF aims to reduce heart failure and prevent ischemic stroke. This is done using daily medication that works towards resetting the heart rhythm and preventing formation of blood clots. Long-term compliance to these daily medications is low and this affects a patient’s quality of life. Ablation of AF is a technique where the diseased tissue in the affected heart chamber is targeted with the intention to apply scars to the atrial tissue and disrupt faulty electrical signals that cause the arrhythmia. Scientific evidence has shown that surgical ablation reduces the both the burden of AF and cardiovascular complications. Previous surgical AF ablation trials had small sample sizes and short follow-up durations which limited conclusions. Catheter-based AF trials suggest intermediate and long-term benefit for cardiovascular outcomes but are limited by some shortcomings. The SAFE trial is an international multicenter randomized controlled trial of 2000 patients with paroxysmal or persistent AF undergoing cardiac surgery for other reasons. Patients will be randomized to either receive concomitant surgical AF ablation or not. This trial will assess whether concomitant surgical ablation of AF decreases the long-term risk of admissions for heart failure in patients with history of non-permanent AF undergoing surgery for another indication. Patients will be followed up for a median of 4 years.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
24/SW/0039
Date of REC Opinion
10 Jul 2024
REC opinion
Further Information Favourable Opinion