Status:
COMPLETED
Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Paroxysmal Atrial Fibrillation
Indications for CABG
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- PAF
- Indication for CABG according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for CABG surgery
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01842529
Start Date
September 1 2012
End Date
December 1 2013
Last Update
January 31 2014
Active Locations (3)
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1
The Valley Health System and Columbia University College of Physicians & Surgeons
New York, New York, United States
2
State Research Institute of Circulation Pathology
Novosibirsk, Russia, 630055
3
Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences
Tomsk, Russia