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Botulinum Toxin Injection to Prevent Ventricular Arrhythmias

M

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

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)

30 participants in 1 patient group

BT injection
Experimental group
Treatment:
Drug: Botulinum Toxin

Trial contacts and locations

1

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Central trial contact

Evgeny Pokushalov, MD, PhD

Data sourced from clinicaltrials.gov

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