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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01842529
First received: April 22, 2013
Last updated: January 30, 2014
Last verified: January 2014

April 22, 2013
January 30, 2014
September 2012
December 2013   (final data collection date for primary outcome measure)
recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01842529 on ClinicalTrials.gov Archive Site
  • time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • post-CABG length of stay [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • incidence of congestive heart failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • incidence of sustained ventricular arrhythmias [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • incidence of myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • incidence of renal failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • incidence of respiratory failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • stroke or transient ischemic attack [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • rehospitalization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • readmission to ICU [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • number of deaths [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • post-CABG length of stay [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Paroxysmal Atrial Fibrillation
  • Indications for CABG
  • Biological: botulinum toxin injection
  • Biological: 0.9% normal saline injection
  • Device: Implantable loop recorder
  • Active Comparator: CABG+ Botulinum toxin
    All patients underwent conventional CABG. After the main stage of the surgery botulinum toxin (Xeomin, incobotulinumtoxin A, Merz Pharma GmbH & Co KGaA, Germany; 50 U/1 mL at each fat pad; botulinum toxin group) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP.
    Interventions:
    • Biological: botulinum toxin injection
    • Device: Implantable loop recorder
  • Active Comparator: Control
    All patients underwent conventional CABG. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad; placebo group) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP.
    Interventions:
    • Biological: 0.9% normal saline injection
    • Device: Implantable loop recorder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   United States
 
NCT01842529
BT13-01
Yes
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Principal Investigator: Evgeny Pokushalov, MD, PhD, FESC State Research Institute of Circulation Pathology
Meshalkin Research Institute of Pathology of Circulation
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP