Botulinum Toxin Injection to Prevent Ventricular Arrhythmias

Phase 1

• Conditions: Symptomatic Ventricular Asystolia; Ventricular Tachycardia
• Interventions: Drug: Botulinum Toxin

• Registration Number: NCT02003001
• 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 ventricular arrhythmias.

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: 2015-09-24
• Last Update Posted: 2015-09-25
• Primary Completion: 2016-03
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• symptomatic ventricular arrhythmias
• drug-resistance
• unsuccessful one or more ablation procedure with future unreasonable tries

Exclusion Criteria

• Previous heart surgery and AF ablation procedure
• Emergency CABG
• Unstable angina or heart failure
• Use antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone)
• Requiring concomitant valve surgery
• Left ventricle ejection fraction <35%
• Unwillingness to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BT injection	Botulinum Toxin	-

Primary Outcome Measures

Name	Time	Method
freedom of ventricular arrhythmias	1 year

Secondary Outcome Measures

Name	Time	Method
serious adverse events	1 year
time to recurrence of ventricular arrhythmias	1 year

Trial Locations

Locations (1)

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