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

Meshalkin Research Institute of Pathology of Circulation3 sites in 2 countries60 target enrollmentSeptember 2012

ConditionsParoxysmal Atrial Fibrillation Indications for CABG

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 60
Locations: 3
Primary Endpoint: recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

December 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Outcomes

Primary Outcomes

recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug

Time Frame: 1 year

Secondary Outcomes

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)