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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: propylactic maze

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals
• Investigators: Principal Investigator: Charles L Willekes, MD, Spectrum Health Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 14, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Coronary Disease; Coronary Artery Disease; Atrial Fibrillation
• Other Study ID Numbers: 2018-157

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes