Sponsor study identifier
observational
151
1 country
1
Study Start
June 8, 2023
Actual (reported)Primary Completion
November 15, 2025
Actual (reported)Study Completion
December 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 8, 2023
Actual (reported)November 15, 2025
Actual (reported)November 15, 2025
Actual (reported)November 19, 2025
Actual (reported)December 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
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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.
Myriam ADDI
Toulouse, French (France), 31400, France
First Submitted
November 15, 2025
First Posted
November 19, 2025
Study Start
June 8, 2023
Actual (reported)Primary Completion
November 15, 2025
The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF
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Study Completion
December 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 5, 2025
Record last verified: 2025-11
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