Modified Left Atrial Maze Procedure for Concomitant AF Ablation

NCT07236398 | Enrolling By Invitation

• 1 other identifier: UPaulSabatierToulouse1
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is the most common sustained arrhythmia and affects up to 60% of patients undergoing cardiac surgery. Restoring sinus rhythm improves symptoms, reduces stroke risk, and prevents heart failure. Despite guideline recommendations, surgical ablation remains underused. This study evaluates the safety and effectiveness of a standardized modified left atrial Maze procedure performed concomitantly with cardiac surgery and identifies early predictors of long-term rhythm success. The procedure consists of creating left atrial lesion sets using radiofrequency, cryothermy, or both, and systematically closing the left atrial appendage to reduce thromboembolic risk. This prospective single-center observational study includes 151 patients undergoing concomitant AF ablation. Follow-up is performed at 3, 6, and 12 months with clinical evaluation, ECG, 24-hour Holter monitoring, pacemaker interrogation when applicable, and a standardized quality-of-life questionnaire. The primary endpoint is sinus rhythm maintenance at 12 months. Secondary endpoints include operative mortality, neurological events, pacemaker implantation, reoperation for bleeding, and quality-of-life changes. The study aims to provide new insights into predictors of success and support standardized follow-up strategies for surgical AF ablation.

Conditions

Atrial Fibrillation; Cardiac Arrhythmia

Keywords

atrial fibrillation; surgical ablation; left Maze; cardiac surgery; rythm monitoring

Outcome Measures

Primary Outcomes (1)

• Maintenance of sinus rhythm at 12 months after modified left atrial Maze procedure, assessed by 24-hour Holter monitoring or pacemaker interrogation

  Sinus rhythm will be assessed at 12 months post-ablation using 24-hour Holter monitoring or pacemaker interrogation. Early rhythm assessment at 3 months is also performed for monitoring purposes.

Interventions

Modified left atrial Maze procedure performed concomitantly with cardiac surgery, including left atrial appendage closure, using bipolar radiofrequency and/or cryotherapy. PROCEDURE

Patients undergo a standardized modified left atrial Maze procedure during cardiac surgery. The procedure includes pulmonary vein isolation using a BOX lesion set (bipolar radiofrequency clamp) for non-mitral surgeries, and an additional mitral line performed with cryotherapy for mitral valve surgeries. Left atrial appendage closure is systematically performed by excision-suture or AtriClip placement. Postoperative management includes beta-blockers, amiodarone when indicated, and lifelong anticoagulation according to guidelines. Rhythm evaluation is conducted at 3 and 12 months using ECG, 24-hour Holter monitoring, or pacemaker interrogation, along with quality-of-life assessment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective single-center observational cohort includes adult patients with documented atrial fibrillation undergoing cardiac surgery at the University Hospital of Toulouse. All eligible patients during the inclusion period were consecutively enrolled and followed for one year.

You may qualify if:

• Age 18 years or older
• Documented history of atrial fibrillation
• Scheduled for cardiac surgery
• Able to understand study information and provide non-opposition consent

You may not qualify if:

• None

Sponsors & Collaborators

• University Paul Sabatier of Toulouse: lead

Study Sites (1)

Myriam ADDI

Toulouse, French (France), 31400, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Cardiovascular Surgery, University Hospital of Toulouse

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 19, 2025
• Study Start: June 8, 2023
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

FR (1)