Clinical trial NCT01842529: Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery
Official title: Botulinum Toxin Injection in Epicardial Fat Pads Can Prevent Recurrences of Atrial Fibrillation After Cardiac Surgery: Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paroxysmal Atrial Fibrillation
Indications for CABG
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug
timeFrame: 1 year
Secondary outcomes:
measure: time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU
timeFrame: 1 year
measure: post-CABG length of stay
timeFrame: 12 months
measure: incidence of congestive heart failure
timeFrame: 12 months
measure: incidence of sustained ventricular arrhythmias
timeFrame: 12 months
measure: incidence of myocardial infarction
timeFrame: 12 months
measure: incidence of renal failure
timeFrame: 12 months
measure: incidence of respiratory failure
timeFrame: 12 months
measure: stroke or transient ischemic attack
timeFrame: 12 months
measure: rehospitalization
timeFrame: 12 months
measure: readmission to ICU
timeFrame: 12 months
measure: number of deaths
timeFrame: 12 months
measure: post-CABG length of stay
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: The Valley Health System and Columbia University College of Physicians & Surgeons
state: New York
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
city: Tomsk
country: Russian Federation
facility: Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny Pokushalov, MD, PhD, FESC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romanov A, Pokushalov E, Ponomarev D, Bayramova S, Shabanov V, Losik D, Stenin I, Elesin D, Mikheenko I, Strelnikov A, Sergeevichev D, Kozlov B, Po SS, Steinberg JS. Long-term suppression of atrial fibrillation by botulinum toxin injection into epicardial fat pads in patients undergoing cardiac surgery: Three-year follow-up of a randomized study. Heart Rhythm. 2019 Feb;16(2):172-177. doi: 10.1016/j.hrthm.2018.08.019. Epub 2018 Nov 7.
citation: Pokushalov E, Kozlov B, Romanov A, Strelnikov A, Bayramova S, Sergeevichev D, Bogachev-Prokophiev A, Zheleznev S, Shipulin V, Lomivorotov VV, Karaskov A, Po SS, Steinberg JS. Long-Term Suppression of Atrial Fibrillation by Botulinum Toxin Injection Into Epicardial Fat Pads in Patients Undergoing Cardiac Surgery: One-Year Follow-Up of a Randomized Pilot Study. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1334-41. doi: 10.1161/CIRCEP.115.003199. Epub 2015 Oct 20.