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
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.
Investigators
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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