Endomyocardial Botulinum Toxin Injection Can Prevent Ventricular Arrhythmias: Pilot Study

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country30 target enrollmentJune 2013

ConditionsSymptomatic Ventricular Asystolia Ventricular Tachycardia

InterventionsBotulinum Toxin

DrugsBotulinum Toxin

Overview

Phase: Phase 1
Intervention: Botulinum Toxin
Conditions: Symptomatic Ventricular Asystolia
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 30
Locations: 1
Primary Endpoint: freedom of ventricular arrhythmias
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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 ventricular arrhythmias.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

December 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

•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