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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Prophylactic limited left sided maze procedure for subjects in the treatment arm
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Incidence of Documented Post-operative Atrial Fibrillation
Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment.
Time frame: From date of index surgical procedure to date of discharge, on average 1 week.
Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group
the utilization of antiarrhythmic medication required to manage postoperative atrial fibrillation will be recorded
Time frame: immediately after procedure/surgery up to discharge from the hospital, average 1 week
Percentage of Adverse Events 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
Time frame: during the procedure/surgery, up to 8 hours
Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group
the utilization of anticoagulant medications required to manage postoperative atrial fibrillation will be recorded
Time frame: immediately after procedure/surgery up to discharge from the hospital, on average 1 week
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