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

Phase 2
Completed
Conditions
Paroxysmal Atrial Fibrillation
Indications for CABG
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

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
Primary Outcome Measures
NameTimeMethod
recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug1 year
Secondary Outcome Measures
NameTimeMethod
time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU1 year
post-CABG length of stay1 year
incidence of congestive heart failure12 months
incidence of sustained ventricular arrhythmias12 months
incidence of myocardial infarction12 months
incidence of renal failure12 months
incidence of respiratory failure12 months
stroke or transient ischemic attack12 months
rehospitalization12 months
readmission to ICU12 months
number of deaths12 months

Trial Locations

Locations (3)

The Valley Health System and Columbia University College of Physicians & Surgeons

🇺🇸

New York, New York, United States

State Research Institute of Circulation Pathology

🇷🇺

Novosibirsk, Russian Federation

Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences

🇷🇺

Tomsk, Russian Federation

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

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