Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT03604432
• Lead Sponsor: Spectrum Health Hospitals

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Study Start: 2020-02-01
• Primary Completion: 2022-12-13
• Study Completion: 2023-02-10
• Results First Submitted: 2023-09-06
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-14
• Last Update Submitted: 2023-10-14
• Results First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Spectrum Health Hospitals; 🇺🇸 Grand Rapids, Michigan, United States