Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery (PREVENT-AF)

Prophylactic Limited Left Sided Maze Procedure to Prevent Post-operative Atrial Fibrillation in Adult Cardiac Surgery Patients

This study will look at performing a prophylactic limited left sided maze procedure during concomitant adult cardiac surgery to prevent the common occurrence of postoperative atrial fibrillation.

This is a prospective, single site, randomized, small feasibility study using a FDA approved device for a new indication. Subjects undergoing a CABG, AVR, or CABG/AVR will be randomized 1 to 1 to a control or treatment group. The control group will undergo their index cardiac surgery procedure only. The treatment group will undergo their index cardiac procedure along with a limited left sided maze procedure. The maze procedure will be done with the Atricure synergy ablation system. This is an FDA approved device that will be used for this new indication. The left sided limited maze procedure will consist of pulmonary vein isolation and removal of the left atrial appendage. A total of 60 subjects will be enrolled in this study at a single site.

Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment.

On average outcome 1 occurs 1 week post-procedure. From date of index surgical procedure to date of discharge from the hospital measured in total days

number of participants requiring antiarrhythmic and anticoagulation medications in the treatment group versus control group

the utilization of antiarrhythmic medication and anticoagulation required to manage postoperative atrial fibrillation will be recorded

incidence of adverse events and outcomes related to use of the radiofrequency device or left atrial appendage amputation

record and describe any patient related morbidity or adverse outcome related to the radiofrequency pulmonary vein isolation or left atrial appendage removal

Inclusion Criteria: Elective cardiac surgery AVR CABG AVR/CABG Exclusion Criteria: History of AF/Aflutter Less common cardiac surgeries: aortic root replacement aortic dissections myxoma pericardectomies off-pump procedures redo procedures Subjects with existing pacemakers, AICD Vulnerable population Emergent surgery Currently participating in investigational drug or device study. Subjects currently on antiarrhythmic drugs Class I and III including amiodarone.