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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Supra-ventricular Tachyarrhythmias

Treatments: Procedure: radiofrequency ablation; Drug: botulinum toxin injection

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02008461

BT_SVT

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

RFA

Active Comparator group

Description:

Mapping and radiofrequency ablation are performed by using standard methods.

Treatment:

Procedure: radiofrequency ablation

RFA+BT injection

Active Comparator group

Description:

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).

Treatment:

Drug: botulinum toxin injection

Procedure: radiofrequency ablation