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NCT02003001 Clinical Trial

Botulinum Toxin Injection to Prevent Ventricular Arrhythmias

Ventricular Tachycardia Clinical Trial

Official title:
Endomyocardial Botulinum Toxin Injection Can Prevent Ventricular Arrhythmias: Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02003001
Other study ID # BT_VA
Secondary ID
Status Recruiting
Phase Phase 1
First received December 2, 2013
Last updated September 24, 2015
Start date June 2013
Est. completion date December 2016

Study information
Verified date September 2015
Source Meshalkin Research Institute of Pathology of Circulation
Contact Evgeny Pokushalov, MD, PhD
Phone +79139254858
Email e.pokushalov@gmail.com
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Botulinum Toxin

Locations
Country Name City State
Russian Federation State Research Institute of Circulation Pathology Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary freedom of ventricular arrhythmias 1 year No
Secondary serious adverse events 1 year Yes
Secondary time to recurrence of ventricular arrhythmias 1 year No
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