Botulinum Toxin Injection to Prevent VT Storm
Endomyocardial Botulinum Toxin Injection Can Decrease the Number of Episodes of VT Storm: Pilot Study
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2013
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 2, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedSeptember 23, 2015
September 1, 2015
2.5 years
December 2, 2013
September 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
number of episodes of VT Storm
1 year
Secondary Outcomes (1)
serious adverse events
1 year
Study Arms (1)
BT injection
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- or more episodes of ventricular tachycardia within 24 hours
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2013
First Posted
December 6, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
September 23, 2015
Record last verified: 2015-09