Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery

NCT ID: NCT03604432

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2023-02-10

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Electric cardiac surgery only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment group

Elective cardiac surgery plus prophylactic maze procedure

Group Type: EXPERIMENTAL

propylactic maze

Intervention Type: DEVICE

Prophylactic limited left sided maze procedure for subjects in the treatment arm

Interventions

propylactic maze

Prophylactic limited left sided maze procedure for subjects in the treatment arm

Intervention Type: DEVICE

Other Intervention Names

Atricure synergy ablation system

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Health Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Charles Willekes

Cardiothoracic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles L Willekes, MD

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Locations

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018-157

Identifier Type: -

Identifier Source: org_study_id