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Completed

NCT Number: NCT01842529

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

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Indications for CABG Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

State Research Institute of Circulation Pathology, Novosibirsk, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

botulinum toxin injection

Biological

0.9% normal saline injection

Biological

Implantable Loop Recorder

Device

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU

    Time frame: 1 year

  2. post-CABG length of stay

    Time frame: 12 months

  3. incidence of congestive heart failure

    Time frame: 12 months

  4. incidence of sustained ventricular arrhythmias

    Time frame: 12 months

  5. incidence of myocardial infarction

    Time frame: 12 months

  6. incidence of renal failure

    Time frame: 12 months

  7. incidence of respiratory failure

    Time frame: 12 months

  8. stroke or transient ischemic attack

    Time frame: 12 months

  9. rehospitalization

    Time frame: 12 months

  10. readmission to ICU

    Time frame: 12 months

  11. number of deaths

    Time frame: 12 months

  12. post-CABG length of stay

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2013
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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