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

Phase 2

Completed

• Conditions: Paroxysmal Atrial Fibrillation; Indications for CABG
• Interventions: Biological: botulinum toxin injection; Biological: 0.9% normal saline injection; Device: Implantable loop recorder

• Registration Number: NCT01842529
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-30
• Last Update Posted: 2014-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CABG+ Botulinum toxin	botulinum toxin injection	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.
CABG+ Botulinum toxin	Implantable loop recorder	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.
Control	0.9% normal saline injection	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.
Control	Implantable loop recorder	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU	1 year
post-CABG length of stay	1 year
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

Trial Locations

Locations (3)

The Valley Health System and Columbia University College of Physicians & Surgeons; 🇺🇸 New York, New York, United States

Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences; 🇷🇺 Tomsk, Russian Federation

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation