Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias
Overview
- Phase
- Phase 2
- Intervention
- radiofrequency ablation
- Conditions
- Supra-ventricular Tachyarrhythmias
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- number of episodes of atrial fibrillation
- Last Updated
- 10 years ago
Overview
Brief Summary
The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were assessed with the use of an implanted monitoring device (IMD).
Investigators
Eligibility Criteria
Inclusion Criteria
- •atrial flutter, AV nodal re-entry tachycardia, focal atrial tachycardia, WPW syndrome
- •secondary atrial fibrillation
Exclusion Criteria
- •congestive heart failure
- •LV ejection fraction \< 35%
- •left atrial diameter \> 60 mm
Arms & Interventions
RFA
Mapping and radiofrequency ablation are performed by using standard methods.
Intervention: radiofrequency ablation
RFA+BT injection
Mapping and radiofrequency ablation are performed by using standard methods. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
Intervention: radiofrequency ablation
RFA+BT injection
Mapping and radiofrequency ablation are performed by using standard methods. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
Intervention: botulinum toxin injection
Outcomes
Primary Outcomes
number of episodes of atrial fibrillation
Time Frame: 1 year
Secondary Outcomes
- serious adverse events(1 year)