Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective randomized double-blind study was to compare the efficacy and safety of Botulinum toxin injection in epicardial fat pads for preventing recurrences (in early postoperative period) of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass graft (CABG) surgery.

Official Title
-----------------
Botulinum Toxin Injection in Epicardial Fat Pads Can Prevent Recurrences of Atrial Fibrillation After Cardiac Surgery: Randomized Pilot Study

Conditions
-----------------
Paroxysmal Atrial Fibrillation, Indications for CABG

Intervention / Treatment
-----------------
* Biological: botulinum toxin injection
* Biological: 0.9% normal saline injection
* Device: Implantable loop recorder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PAF Indication for CABG according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for CABG surgery Exclusion Criteria: Previous heart surgery and AF ablation procedure Emergency CABG Unstable angina or heart failure Persistent AF, AF at the time of screening (planned Maze procedure or pulmonary vein isolation) Use of I or III antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone) Requiring concomitant valve surgery Left ventricle ejection fraction <35% Left atrial diameter >55 mm Unwillingness to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CABG+ Botulinum toxin<br>All patients underwent conventional CABG. After the main stage of the surgery botulinum toxin (Xeomin, incobotulinumtoxin A, Merz Pharma GmbH & Co KGaA, Germany; 50 U/1 mL at each fat pad; botulinum toxin group) 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. | Biological: botulinum toxin injection<br> <br> Device: Implantable loop recorder<br> <br> |
| Active Comparator: Control<br>All patients underwent conventional CABG. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad; placebo group) 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. | Biological: 0.9% normal saline injection<br> <br> Device: Implantable loop recorder<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug |  | 1 year | 

Secondary Outcome Measures

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