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

Primary Purpose

Paroxysmal Atrial Fibrillation, Indications for CABG

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
botulinum toxin injection
0.9% normal saline injection
Implantable loop recorder
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Valley Health System and Columbia University College of Physicians & Surgeons
  • State Research Institute of Circulation Pathology
  • Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CABG+ Botulinum toxin

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU
post-CABG length of stay
incidence of congestive heart failure
incidence of sustained ventricular arrhythmias
incidence of myocardial infarction
incidence of renal failure
incidence of respiratory failure
stroke or transient ischemic attack
rehospitalization
readmission to ICU
number of deaths
post-CABG length of stay

Full Information

First Posted
April 22, 2013
Last Updated
January 30, 2014
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT01842529
Brief Title
Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery
Official Title
Botulinum Toxin Injection in Epicardial Fat Pads Can Prevent Recurrences of Atrial Fibrillation After Cardiac Surgery: Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Indications for CABG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CABG+ Botulinum toxin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
botulinum toxin injection
Intervention Type
Biological
Intervention Name(s)
0.9% normal saline injection
Intervention Type
Device
Intervention Name(s)
Implantable loop recorder
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU
Time Frame
1 year
Title
post-CABG length of stay
Time Frame
12 months
Title
incidence of congestive heart failure
Time Frame
12 months
Title
incidence of sustained ventricular arrhythmias
Time Frame
12 months
Title
incidence of myocardial infarction
Time Frame
12 months
Title
incidence of renal failure
Time Frame
12 months
Title
incidence of respiratory failure
Time Frame
12 months
Title
stroke or transient ischemic attack
Time Frame
12 months
Title
rehospitalization
Time Frame
12 months
Title
readmission to ICU
Time Frame
12 months
Title
number of deaths
Time Frame
12 months
Title
post-CABG length of stay
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD, FESC
Organizational Affiliation
State Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Valley Health System and Columbia University College of Physicians & Surgeons
City
New York
State/Province
New York
Country
United States
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences
City
Tomsk
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
30414841
Citation
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.
Results Reference
derived
PubMed Identifier
26486855
Citation
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.
Results Reference
derived
Links:
URL
http://meshalkin.ru
Description
State Research Institute of Circulation Pathology Official Site

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

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