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Clinical Trials/NCT02003027
NCT02003027
Unknown
Phase 1

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

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country15 target enrollmentJune 2013
ConditionsVT Storm
InterventionsBT injection

Overview

Phase
Phase 1
Intervention
BT injection
Conditions
VT Storm
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Enrollment
15
Locations
1
Primary Endpoint
number of episodes of VT Storm
Last Updated
10 years ago

Overview

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 episodes of VT Storm.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
January 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Meshalkin Research Institute of Pathology of Circulation
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

BT injection

Intervention: BT injection

Outcomes

Primary Outcomes

number of episodes of VT Storm

Time Frame: 1 year

Secondary Outcomes

  • serious adverse events(1 year)

Study Sites (1)

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