Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: propylactic maze


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Electric cardiac surgery only | |
| Experimental: Treatment group<br>Elective cardiac surgery plus prophylactic maze procedure | Device: propylactic maze<br>* Prophylactic limited left sided maze procedure for subjects in the treatment arm<br>* Other names: Atricure synergy ablation system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Documented Post-operative Atrial Fibrillation | Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment. | From date of index surgical procedure to date of discharge, on average 1 week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | immediately after procedure/surgery up to discharge from the hospital, on average 1 week |