Comparing Surgical Management Methods of Atrial Fibrillation

NCT ID: NCT07100483

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2032-09-15

Brief Summary

Compare the efficacy of the left atrial Cox-Maze IV lesion set versus the Tampa 2 lesion set versus the EnCompass ablation alone, in the surgical treatment of atrial fibrillation at one year post-operatively.

Detailed Description

This is a single center prospective, randomized trial to compare the outcomes, specifically the freedom from atrial fibrillation at one year, and possibly up to five years, of three different approaches to the cardiac surgical management of atrial fibrillation.

Several strategies to accomplish surgical ablation are acceptable and have been shown retrospectively to be successful. The Cox-Maze bi-atrial, left and right atrial lesions, ablation (whether III or IV) remains the gold standard by which all surgical ablations are compared. Further refinement in ablation technology and research has further suggested there is no difference between a left atrial ablation alone or bi-atrial ablation lesion set. For left atrial ablation alone, existent therapeutic options, which all meet equivalent standard of care, include a left atrial Cox-Maze IV , a Tampa 2 lesion set or utilizing a "box lesion" alone. Currently, there are no randomized, clinical trials demonstrating better efficacy (freedom from atrial fibrillation post-operatively) of one ablation strategy over another in patients undergoing cardiac surgery.

The rationale for the study is to demonstrate whether one ablation technique is more efficacious in the surgical treatment of AF. Should one technique prove superior it may clarify the question of which ablation strategy to utilize and encourage surgeons to implement a consistent approach to surgical ablation.

To our knowledge this study would be the first prospective, randomized trial in the United States comparing surgical lesion sets in the concomitant management of atrial fibrillation.

Conditions

Atrial Fibrillation

Study Design

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

Study Groups

Cox-Maze IV

Lesion created around the pulmonary vein ostia (openings). Lesion to posterior (back) of the mitral annulus (fibrous ring around the mitral valve leaflets). Lesion from the 'box' to the left atrial appendage. There is also one lesion on the outside of the heart at the coronary sinus (main vein draining the heart)- not shown in this picture due to being on the outside of the heart. The Left Atrial Appendage will also be either excluded or removed.

Group Type: ACTIVE_COMPARATOR

Atrial Fibrillation Ablation

Intervention Type: PROCEDURE

Ablation of the heart to reduce Afib Occurrence

Tampa 2

Lesion created around the pulmonary vein ostia (openings). Lesion from the 'box' to the left atrial appendage Lesion from the left atrial appendage to the anterior (front) of the mitral annulus (fibrous ring around the mitral valve leaflets). This lesion is done through the left atrial appendage. The Left Atrial Appendage will also be either excluded or removed.

Group Type: ACTIVE_COMPARATOR

Atrial Fibrillation Ablation

Intervention Type: PROCEDURE

Ablation of the heart to reduce Afib Occurrence

Encompass Alone

Lesion created around the pulmonary vein ostia (openings). The Left Atrial Appendage will also be either excluded or removed.

Group Type: ACTIVE_COMPARATOR

Atrial Fibrillation Ablation

Intervention Type: PROCEDURE

Ablation of the heart to reduce Afib Occurrence

Interventions

Atrial Fibrillation Ablation

Ablation of the heart to reduce Afib Occurrence

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adult patients with a history of preoperative atrial fibrillation, either paroxysmal or persistent, requiring concomitant surgical ablation who are scheduled to undergo cardiac surgical procedure(s) to be performed on cardiopulmonary bypass
• Utilizing sternotomy approach requiring cardiopulmonary bypass
• Male or Female subjects between age 18 to 85 years of age

Exclusion Criteria

• LVEF < 25%
• LAVI > 59ml/m②
• Presence of Pacemaker/AICD
• History of VT/VF, WPW
• Re-operative cardiac surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corewell Health West

OTHER

Sponsor Role: lead

Responsible Party

Charles Willekes

Section Chief Cardiothoracic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Willekes, MD

Role: PRINCIPAL_INVESTIGATOR

Corewell Health

Locations

Corewell Health

Grand Rapids, Michigan, United States

Countries

United States

Other Identifiers

2025-1012

Identifier Type: -

Identifier Source: org_study_id