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

Completed · Phase 2

Conditions studied: Paroxysmal Atrial Fibrillation, Indications for CABG

In brief

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.

Key facts

Study ID

NCT01842529

Run by

Meshalkin Research Institute of Pathology of Circulation

People needed

60

Starts

2012-09-01

Expected to finish

2013-12-01

Last updated by the study team

2014-01-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• PAF
• Indication for CABG according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for CABG surgery

You may not qualify if…

• 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

Where it is running

• The Valley Health System and Columbia University College of Physicians & Surgeons — New York, New York, United States
• State Research Institute of Circulation Pathology — Novosibirsk, Russia
• Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences — Tomsk, Russia

Full record on ClinicalTrials.gov

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