NCT01842529

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

April 22, 2013

Last Update Submit

January 30, 2014

Conditions

Paroxysmal Atrial FibrillationIndications for CABG

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (12)

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

    1 year

  • 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

  • +7 more secondary outcomes

Study Arms (2)

CABG+ Botulinum toxin

ACTIVE COMPARATOR

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 injectionDevice: Implantable loop recorder

Control

ACTIVE COMPARATOR

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 injectionDevice: Implantable loop recorder

Interventions

botulinum toxin injectionBIOLOGICAL
CABG+ Botulinum toxin
0.9% normal saline injectionBIOLOGICAL
Control
Implantable loop recorderDEVICE
CABG+ Botulinum toxinControl

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PAF
  • Indication for CABG according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for CABG surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Valley Health System and Columbia University College of Physicians & Surgeons

New York, New York, United States

Location

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences

Tomsk, Russia

Location

Related Publications (2)

  • Romanov A, Pokushalov E, Ponomarev D, Bayramova S, Shabanov V, Losik D, Stenin I, Elesin D, Mikheenko I, Strelnikov A, Sergeevichev D, Kozlov B, Po SS, Steinberg JS. Long-term suppression of atrial fibrillation by botulinum toxin injection into epicardial fat pads in patients undergoing cardiac surgery: Three-year follow-up of a randomized study. Heart Rhythm. 2019 Feb;16(2):172-177. doi: 10.1016/j.hrthm.2018.08.019. Epub 2018 Nov 7.

    PMID: 30414841DERIVED

  • Pokushalov E, Kozlov B, Romanov A, Strelnikov A, Bayramova S, Sergeevichev D, Bogachev-Prokophiev A, Zheleznev S, Shipulin V, Lomivorotov VV, Karaskov A, Po SS, Steinberg JS. Long-Term Suppression of Atrial Fibrillation by Botulinum Toxin Injection Into Epicardial Fat Pads in Patients Undergoing Cardiac Surgery: One-Year Follow-Up of a Randomized Pilot Study. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1334-41. doi: 10.1161/CIRCEP.115.003199. Epub 2015 Oct 20.

    PMID: 26486855DERIVED

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Botulinum ToxinsSaline Solution

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Evgeny Pokushalov, MD, PhD, FESC

    State Research Institute of Circulation Pathology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 29, 2013

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

RU(2)US(1)