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

Phase 2UnknownNCT02008461

Meshalkin Research Institute of Pathology of Circulation60 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Supra-ventricular Tachyarrhythmias

Interventions

radiofrequency ablationPROCEDURE

botulinum toxin injectionDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Rochester

Rochester, New York, United States

ACTIVE_NOT_RECRUITING

State Research Institute of Circulation Pathology

Novosibirsk, Russia

RECRUITING

Outcomes

Primary Outcomes

number of episodes of atrial fibrillation

Time frame: 1 year

Secondary Outcomes

serious adverse events

Time frame: 1 year

Central Contacts

Evgeny Pokushalov, MD, PhD

CONTACT

+79139254858 e.pokushalov@gmail.com

Data from ClinicalTrials.gov

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