NCT07236398Enrolling by invitation
Modified Left Atrial Maze Procedure for Concomitant AF Ablation
Modified Left Atrial Maze Procedure: Achieving a Balance Between Safety and Efficacy in Concomitant Atrial Fibrillation Ablation
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 151 (estimated)
- First submitted
- 15 Nov 2025
- Start date
- 8 Jun 2023
- Primary completion date
- 15 Nov 2025
- Lead sponsor
- University Paul Sabatier of Toulouse
- Diseases
- Atrial fibrillation
- NCT number
- NCT07236398
What you commit to
- Study type: Observational
- Planned participants: 151
- From 8 Jun 2023 to the primary completion date, 15 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- Age 18 years or older
- Documented history of atrial fibrillation
- Scheduled for cardiac surgery
- Able to understand study information and provide non-opposition consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Myriam ADDI Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.