Comparing Surgical Management Methods of Atrial Fibrillation

NCT07100483 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 2025-1012
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

AFib; Ablation; Cox IV; Tampa 2; Encompass; Box Lesion

Outcome Measures

Primary Outcomes (1)

• Freedom from Atrial Fibrillation

  Freedom from atrial fibrillation at 30 days and one year

  30 days and 1 year

Secondary Outcomes (1)

• Prescribed Antiarrhythmic and anticoagulant drugs

  7 days and 1 year

Study Arms (3)

Cox-Maze IV

ACTIVE COMPARATOR

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.

Procedure: Atrial Fibrillation Ablation

Tampa 2

ACTIVE COMPARATOR

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.

Procedure: Atrial Fibrillation Ablation

Encompass Alone

ACTIVE COMPARATOR

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

Procedure: Atrial Fibrillation Ablation

Interventions

Atrial Fibrillation Ablation PROCEDURE

Ablation of the heart to reduce Afib Occurrence

Cox-Maze IV; Encompass Alone; Tampa 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Corewell Health West

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Willekes, MD

  Corewell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief Cardiothoracic surgery

Model Details: This is a single enter 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 (Cox-Maze IV, Tampa 2, Encompass) to the cardiac surgical management of atrial fibrillation. All patients undergoing an elective, cardiac surgical procedure with documented preoperative AF, either paroxysmal or persistent, with a planned surgical ablation are potential candidates.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 3, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2032
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)