Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery
Paroxysmal Atrial Fibrillation, Indications for CABG
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
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
Sites / Locations
- The Valley Health System and Columbia University College of Physicians & Surgeons
- State Research Institute of Circulation Pathology
- Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
CABG+ Botulinum toxin
Control
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.
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.