Botulinum Toxin Injection to Prevent Ventricular Arrhythmias
Phase 1
- Conditions
- Symptomatic Ventricular AsystoliaVentricular Tachycardia
- Interventions
- Registration Number
- NCT02003001
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BT injection Botulinum Toxin -
- Primary Outcome Measures
Name Time Method freedom of ventricular arrhythmias 1 year
- Secondary Outcome Measures
Name Time Method serious adverse events 1 year time to recurrence of ventricular arrhythmias 1 year
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie botulinum toxin's anti-arrhythmic effects in the left ventricle?
How does endomyocardial botulinum toxin injection compare to standard anti-arrhythmic therapies in preventing ventricular tachycardia and asystolia?
What biomarkers are associated with response to botulinum toxin treatment in patients with ventricular arrhythmias?
What are the potential adverse events and management strategies for botulinum toxin injections in the left ventricle?
Are there combination therapies or alternative neurotoxins being explored for treating ventricular arrhythmias similar to NCT02003001?
Trial Locations
- Locations (1)
State Research Institute of Circulation Pathology
🇷🇺Novosibirsk, Russian Federation
State Research Institute of Circulation Pathology🇷🇺Novosibirsk, Russian FederationEvgeny Pokushalov, MD, PhDPrincipal Investigator