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
  Purpose

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.


Condition Intervention Phase
Paroxysmal Atrial Fibrillation
Indications for CABG
Biological: botulinum toxin injection
Biological: 0.9% normal saline injection
Device: Implantable loop recorder
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Injection in Epicardial Fat Pads Can Prevent Recurrences of Atrial Fibrillation After Cardiac Surgery: Randomized Pilot Study

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Biological: 0.9% normal saline injection Device: Implantable loop recorder

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842529

Locations
United States, New York
The Valley Health System and Columbia University College of Physicians & Surgeons
New York, New York, United States
Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation, 630055
Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences
Tomsk, Russian Federation
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny Pokushalov, MD, PhD, FESC State Research Institute of Circulation Pathology
  More Information

Additional Information:
No publications provided

Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01842529     History of Changes
Other Study ID Numbers: BT13-01
Study First Received: April 22, 2013
Last Updated: January 30, 2014
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014