Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery

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.

• propylactic maze (Device), also known as Atricure synergy ablation system: Prophylactic limited left sided maze procedure for subjects in the treatment arm

Primary outcomes

• Incidence of Documented Post-operative Atrial Fibrillation [From date of index surgical procedure to date of discharge, on average 1 week.]: Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment.

Secondary outcomes

• Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group [immediately after procedure/surgery up to discharge from the hospital, average 1 week]: the utilization of antiarrhythmic medication required to manage postoperative atrial fibrillation will be recorded
• Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation. [during the procedure/surgery, up to 8 hours]: record and describe any patient related morbidity or adverse outcome related to the radiofrequency pulmonary vein isolation or left atrial appendage removal
• Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group [immediately after procedure/surgery up to discharge from the hospital, on average 1 week]: the utilization of anticoagulant medications required to manage postoperative atrial fibrillation will be recorded

Sex: All, ages: 70 Years to any

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.

Participant flow

Outcome results

• Incidence of Documented Post-operative Atrial Fibrillation (Primary), Count of participants, Participants: Control Group 17; Treatment Group 2
• Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group (Secondary), Count of participants, Participants: Control Group 14; Treatment Group 2
• Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation. (Secondary), Mean, percentage of events: Control Group 0 +/- 0; Treatment Group 0 +/- 0
• Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group (Secondary), Count of participants, Participants: Control Group 7; Treatment Group 1

Adverse events

Time frame: 1 year

Serious adverse events by term

Other adverse events by term

• Results publication: Willekes CL, Fanning JS, Heiser JC, Wai Sang SL, Timek TA, Parker J, Ragagni MK. Randomized feasibility trial of prophylactic radiofrequency ablation to prevent atrial fibrillation after cardiac surgery. J Thorac Cardiovasc Surg. 2024 Jun;167(6):2129-2135.e1. doi: 10.1016/j.jtcvs.2023.03.010. Epub 2023 Mar 17. PMID 36933787

• Study Protocol and Statistical Analysis Plan (PDF, 2020-02-17)
• Informed Consent Form (PDF, 2021-04-07)

• Charles L Willekes, MD, Principal investigator, Corewell Health West