Botulinum Toxin Injection to Prevent VT Storm

Phase 1

• Conditions: VT Storm
• Interventions: Drug: BT injection

• Registration Number: NCT02003027
• Lead Sponsor: 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 episodes of VT Storm.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BT injection	BT injection	-

Primary Outcome Measures

Name	Time	Method
number of episodes of VT Storm	1 year

Secondary Outcome Measures

Name	Time	Method
serious adverse events	1 year

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation