Botulinum Toxin Injection to Prevent Ventricular Arrhythmias

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 1

Conditions: Symptomatic Ventricular Asystolia; Ventricular Tachycardia

Treatments: Drug: Botulinum Toxin

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02003001

BT_VA

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

BT injection

Experimental group

Treatment:

Drug: Botulinum Toxin