Botulinum Toxin Injection to Prevent VT Storm

September 21, 2015 updated by: Meshalkin Research Institute of Pathology of Circulation

Endomyocardial Botulinum Toxin Injection Can Decrease the Number of Episodes of VT Storm: Pilot Study

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 episodes of VT Storm.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Recruiting
        • State Research Institute of Circulation Pathology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 3 or more episodes of ventricular tachycardia within 24 hours

Exclusion Criteria:

  • Failure to provide informed consent.
  • Non-cardiac illness with a life expectancy of less than 3 year
  • Non-cardiac illness imposing substantial operative mortality
  • Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BT injection
Drug: BT injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of episodes of VT Storm
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
serious adverse events
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 2, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • BT_VT Storm

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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