The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation

Study Overview
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Brief Summary
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The aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in 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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Injection of the New Pharmaceutical Composition Containing Botulinum Toxin Into Epicardial Fat Pads to Treat Atrial Fibrillation After Coronary Artery Bypass Grafting

Conditions
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Atrial Fibrillation, Ischemic Heart Disease

Intervention / Treatment
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* Drug: Pharmaceutical composition containing botulinum toxin
* Drug: 0.9% normal saline
* Procedure: Coronary artery bypass grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with paroxysmal AF (recurrent episodes for at least 2 years, with ≥ 6 episodes over the last 6 months) At least one failed antiarrhythmic drug 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 or atrial fibrillation at the time of screening 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>All patients underwent conventional CABG surgery. After the main stage of the surgery new pharmaceutical composition containing botulinum toxin (50 U/1 mL) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right ganglionated plexi (GP); second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior pulmonary vein (PV) and left inferior PV (between the PVs and left atrial appendage (LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP | Drug: Pharmaceutical composition containing botulinum toxin<br> <br> Procedure: Coronary artery bypass grafting<br> <br> |
| Active Comparator: Group 2<br>All patients underwent conventional cardiac surgery. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP | Drug: 0.9% normal saline<br> <br> Procedure: Coronary artery bypass grafting<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from any atrial tachyarrhythmias | Recurrence of >30 s of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of deaths |  | 12 month | 
| time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU |  | 1 month | 
| incidence of congestive heart failure |  | 12 month | 
| incidence of sustained ventricular arrhythmias |  | 12 month | 
| stroke or transient ischemic attack |  | 12 month | 
| incidence of myocardial infarction |  | 12 month | 
| rehospitalization |  | 12 months | 

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