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Botulinum Toxin Injection Into Epicardial Fat Pads to Prevent Atrial Fibrillation in Patients Undergoing Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02617069
Recruitment Status : Unknown
Verified September 2017 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : November 30, 2015
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Brief Summary:
The aim of this prospective randomized double-blind study was to compare the efficacy of botulinum toxin injection in epicardial fat pads for preventing recurrences (in early postoperative period) of atrial tachyarrhythmia in patients undergoing cardiac surgery.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Biological: botulinum toxin injection Biological: 0.9% normal saline injection Device: Implantable loop recorder Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Injection Into Epicardial Fat Pads to Prevent Atrial Fibrillation in Patients Undergoing Cardiac Surgery: Randomized Study
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 (Cardiac surgery+botulinum toxin)
All patients underwent conventional cardiac surgery. After the main stage of the surgery botulinum toxin (50 U/1 mL) 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 ganglionated plexi (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 pulmonary vein (PV) and left inferior PV (between the PVs and left atrial appendage (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: Group 2 (Cardiac surgery+placebo)
All patients underwent conventional cardiac surgery. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad) 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



Primary Outcome Measures :
  1. Recurrence of >30 s of any atrial tachyarrhythmia, including atrial fibrillation (AF) and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Recurrence of >30 s of any atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug. [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key inclusion Criteria:

  • Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery

Key exclusion Criteria:

  • Planned maze procedure or pulmonary vein isolation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617069


Contacts
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Contact: Evgeny Pokushalov, Prof, MD, PhD +73833327655 E.pokushalov@gmail.com
Contact: Marina Nikitenko +73833327655 nikitenko.marina.maratovna@gmail.com

Locations
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Russian Federation
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny Pokushalov, MD, PhD    +79139254858    E.Pokushalov@gmail.com   
Principal Investigator: Evgeny Pokushalov, MD, PhD         
Sub-Investigator: Alexander Romanov, MD, PhD         
Sub-Investigator: Denis Losik         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02617069    
Other Study ID Numbers: NTPAF-01
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Atrial fibrillation
botulinum toxin
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs