Epicardial Fat Pads Ablation During Coronary Surgery

Study Overview
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Brief Summary
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The aim of this prospective randomized study was to assess the efficacy of ablation of the ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.

Official Title
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Ablation of the Epicardial Fat Pads to Treat Paroxysmal Atrial Fibrillation During Coronary Artery Bypass Grafting

Conditions
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Atrial Fibrillation, Ischemic Heart Disease

Intervention / Treatment
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* Procedure: Coronary artery bypass grafting
* Procedure: Epicardial ganglionated plexi ablation
* Procedure: implantable loop recorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of paroxysmal atrial fibrillation (recurrent episodes for at least 1 years, with 2 documented episodes over the last 6 months) Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery Exclusion Criteria: Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation Planned maze procedure or pulmonary vein isolation Unwillingness to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Coronary artery bypass grafting + epicardial ganglionated plexi ablation | Procedure: Coronary artery bypass grafting<br> <br> Procedure: Epicardial ganglionated plexi ablation<br> <br> Procedure: implantable loop recorder<br> <br> |
| Active Comparator: Group 2<br>Coronary artery bypass grafting | Procedure: Coronary artery bypass grafting<br> <br> Procedure: implantable loop recorder<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atrial fibrillation burden |  | 12 month | 
| incidence of congestive heart failure |  | 12 month | 
| incidence of sustained ventricular arrhythmias |  | 12 month | 
| rehospitalization |  | 12 month | 
| stroke or transient ischemic attack |  | 12 month | 
| number of Deaths |  | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic heart disease, atrial fibrillation, ganglionated plexi