NCT03604432

Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Corewell Health West · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	propylactic maze	Prophylactic limited left sided maze procedure for subjects in the treatment arm

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-12-13
• Completion: 2023-02-10
• First posted: 2018-07-27
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study