Efficacy Study for Surgery After Previous Failed Catheter Ablation

Study Overview
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Brief Summary
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Specific Aims: The primary objective of this registry is to determine the percentage of patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical ablation procedure when the patient has a history of failing one or more previous catheter based ablations for AF. The first 3 months following surgical ablation will be a blanking period; any arrhythmia occurring during this time will not be used to determine success. Primary Objectives: Determine the percent success of surgical ablation for AF at 6, and 12 months both on and off of antiarrhythmic drugs (AAD) following a failed catheter based ablation for AF Record and evaluate all complications associated with the surgical procedure. Secondary Objectives: Evaluate usage of anticoagulants at 6, and 12 months. Determine the percentage of Pulmonary Veins (PV) that were electrically isolated by intra-operative, pre-surgical mapping

Official Title
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Surgery After Previous Failed Catheter Ablation

Conditions
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Atrial Fibrillation Ablation

Intervention / Treatment
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* Procedure: Totally Thoracoscopic Maze


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of atrial fibrillation Has undergone one or more catheter based ablation procedures for AF and the procedure failed Has undergone a minimal access surgical ablation procedure for the treatment of AF following failure of catheter based ablation for AF

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical ablation<br>Patients undergoing surgical ablation for Atrial Fibrillation that have failed one or more previous attempts at catheter ablation for Atrial Fibrillation | Procedure: Totally Thoracoscopic Maze<br>* Epicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician<br>* Other names: Cox Maze procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of surgical ablation for AF at 6, & 12 months both on and off of antiarrhythmic drugs following a failed catheter based ablation for AF. |  | 1 year post operatively | 
| Record and evaluate all complications associated with the surgical procedure. |  | 1 year post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate usage of anticoagulants at 6 and 12 months. |  | 1 year post operatively | 
| Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping. |  | 1 year post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Maze, Ablation