Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias

Phase 2

• Conditions: Supra-ventricular Tachyarrhythmias
• Interventions: Procedure: radiofrequency ablation; Drug: botulinum toxin injection

• Registration Number: NCT02008461
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23
• Primary Completion: 2015-12
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA	radiofrequency ablation	Mapping and radiofrequency ablation are performed by using standard methods.
RFA+BT injection	radiofrequency ablation	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).
RFA+BT injection	botulinum toxin 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).

Primary Outcome Measures

Name	Time	Method
number of episodes of atrial fibrillation	1 year

Secondary Outcome Measures

Name	Time	Method
serious adverse events	1 year

Trial Locations

Locations (2)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation

University of Rochester; 🇺🇸 Rochester, New York, United States