Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery

Coronary Artery Disease Clinical Trial

— PREVENT-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604432
• Other study ID #: 2018-157
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 10, 2023

Study information

• Verified date: October 2023
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 10, 2023
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease

Intervention

Device:
• propylactic maze
Prophylactic limited left sided maze procedure for subjects in the treatment arm

Locations

Country	Name	City	State
United States	Spectrum Health Hospitals	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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