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Botulinum Toxin Injection to Prevent Ventricular Arrhythmias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003001
Recruitment Status : Unknown
Verified September 2015 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : December 6, 2013
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Brief Summary:
The aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in left ventricle for preventing ventricular arrhythmias.

Condition or disease Intervention/treatment Phase
Symptomatic Ventricular Asystolia Ventricular Tachycardia Drug: Botulinum Toxin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endomyocardial Botulinum Toxin Injection Can Prevent Ventricular Arrhythmias: Pilot Study
Study Start Date : June 2013
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Arm Intervention/treatment
Experimental: BT injection Drug: Botulinum Toxin



Primary Outcome Measures :
  1. freedom of ventricular arrhythmias [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. serious adverse events [ Time Frame: 1 year ]
  2. time to recurrence of ventricular arrhythmias [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptomatic ventricular arrhythmias
  • drug-resistance
  • unsuccessful one or more ablation procedure with future unreasonable tries

Exclusion Criteria:

  • Previous heart surgery and AF ablation procedure
  • Emergency CABG
  • Unstable angina or heart failure
  • Use 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%
  • Unwillingness to participate

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): NCT02003001


Contacts
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Contact: Evgeny Pokushalov, MD, PhD +79139254858 e.pokushalov@gmail.com

Locations
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Russian Federation
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny Pokushalov, MD, PhD         
Principal Investigator: Evgeny Pokushalov, MD, PhD         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Additional Information:
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02003001    
Other Study ID Numbers: BT_VA
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Heart Arrest
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs