RecruitingNot ApplicableNCT05434819

Surgical Ablation of AF Efficacy Trial

Sponsor

Population Health Research Institute

Enrollment

2,000 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure Atrial Fibrillation

Summary

SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether performing a surgical ablation (a procedure to correct abnormal heart rhythms) during another planned heart surgery reduces atrial fibrillation (AFib) long-term. You may be eligible if... - You are 18 or older - You are already scheduled for heart surgery (coronary bypass, aortic valve replacement, or ascending aorta replacement) - You have a documented history of paroxysmal (intermittent) or persistent atrial fibrillation - You have provided informed consent You may NOT be eligible if... - Your main heart rhythm problem is atrial flutter (not AFib) - Your left atrium (heart chamber) is 6 cm or larger in diameter - You have had previous heart surgery requiring the chest to be opened - You are having a heart transplant, complex congenital heart surgery, ventricular assist device insertion, or mitral/tricuspid valve surgery - You live in a long-term care facility Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgical 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.