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

Botulinum Toxin Injection in Epicardial Fat Pads Can Prevent Recurrences of Atrial Fibrillation After Cardiac Surgery: Randomized Pilot Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01842529

Enrollment

Registered

2013-04-29

Start date

2012-09-30

Completion date

2013-12-31

Last updated

2014-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation, Indications for CABG

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.

Interventions

BIOLOGICALbotulinum toxin injection

BIOLOGICAL0.9% normal saline injection

DEVICEImplantable loop recorder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug	1 year

Secondary

Measure	Time frame
post-CABG length of stay	12 months
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
time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU	1 year
stroke or transient ischemic attack	12 months
rehospitalization	12 months
readmission to ICU	12 months
number of deaths	12 months
incidence of respiratory failure	12 months

Countries

Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026