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

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842529
• Other study ID #: BT13-01
• Status: Completed
• Phase: Phase 2
• First received: April 22, 2013
• Last updated: January 30, 2014
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Indications for CABG
• Paroxysmal Atrial Fibrillation

Intervention

Biological:
• botulinum toxin injection

• 0.9% normal saline injection

Device:
• Implantable loop recorder

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug		1 year	Yes
Secondary	time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU		1 year	Yes
Secondary	post-CABG length of stay		12 months	Yes
Secondary	incidence of congestive heart failure		12 months	Yes
Secondary	incidence of sustained ventricular arrhythmias		12 months	Yes
Secondary	incidence of myocardial infarction		12 months	Yes
Secondary	incidence of renal failure		12 months	Yes
Secondary	incidence of respiratory failure		12 months	Yes
Secondary	stroke or transient ischemic attack		12 months	Yes
Secondary	rehospitalization		12 months	Yes
Secondary	readmission to ICU		12 months	Yes
Secondary	number of deaths		12 months	Yes
Secondary	post-CABG length of stay		1 year	No

External Links

•   State Research Institute of Circulation Pathology Official Site