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Modified Left Atrial Maze Procedure for Concomitant AF Ablation
Sponsor: University Paul Sabatier of Toulouse
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.
Official title: Modified Left Atrial Maze Procedure: Achieving a Balance Between Safety and Efficacy in Concomitant Atrial Fibrillation Ablation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
151
Start Date
2023-06-08
Completion Date
2025-12-15
Last Updated
2025-12-05
Healthy Volunteers
No
Conditions
Interventions
Modified left atrial Maze procedure performed concomitantly with cardiac surgery, including left atrial appendage closure, using bipolar radiofrequency and/or cryotherapy.
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.
Locations (1)
Myriam ADDI
Toulouse, French (France), France