Botulinum Toxin Injection to Prevent Ventricular Arrhythmias

Phase 1UnknownNCT02003001

Meshalkin Research Institute of Pathology of Circulation30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Symptomatic Ventricular Asystolia Ventricular Tachycardia

Interventions

Botulinum ToxinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

State Research Institute of Circulation Pathology

Novosibirsk, Russia

RECRUITING

Outcomes

Primary Outcomes

freedom of ventricular arrhythmias

Time frame: 1 year

Secondary Outcomes

serious adverse events

Time frame: 1 year

time to recurrence of ventricular arrhythmias

Time frame: 1 year

Central Contacts

Evgeny Pokushalov, MD, PhD

CONTACT

+79139254858 e.pokushalov@gmail.com

Data from ClinicalTrials.gov

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