Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery
- Conditions
- Paroxysmal Atrial FibrillationIndications 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
- PAF
- Indication for CABG according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for CABG surgery
- 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
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
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