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Botulinum Toxin Injection to Prevent Ventricular Arrhythmias

Endomyocardial Botulinum Toxin Injection Can Prevent Ventricular Arrhythmias: Pilot Study

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02003001
Enrollment
30
Registered
2013-12-06
Start date
2013-06-30
Completion date
2016-12-31
Last updated
2015-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Ventricular Asystolia, Ventricular Tachycardia

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.

Interventions

DRUGBotulinum Toxin

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
freedom of ventricular arrhythmias1 year

Secondary

MeasureTime frame
serious adverse events1 year
time to recurrence of ventricular arrhythmias1 year

Countries

Russia

Contacts

Primary ContactEvgeny Pokushalov, MD, PhD
e.pokushalov@gmail.com+79139254858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026