Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery (PREVENT-AF)

Spectrum Health Hospitals

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: propylactic maze

Study type: Interventional

Funder types: Other

Identifiers

NCT03604432

2018-157

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control group

No Intervention group

Description:

Electric cardiac surgery only

Treatment group

Experimental group

Description:

Elective cardiac surgery plus prophylactic maze procedure

Treatment:

Device: propylactic maze