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

NCT ID: NCT02008461

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-02-29

Brief Summary

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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

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Conditions

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Supra-ventricular Tachyarrhythmias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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RFA

Mapping and radiofrequency ablation are performed by using standard methods.

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type PROCEDURE

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).

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type PROCEDURE

botulinum toxin injection

Intervention Type DRUG

Interventions

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radiofrequency ablation

Intervention Type PROCEDURE

botulinum toxin injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Rochester

Rochester, New York, United States

Site Status ACTIVE_NOT_RECRUITING

State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status RECRUITING

Countries

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United States Russia

Central Contacts

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Evgeny Pokushalov, MD, PhD

Role: CONTACT

+79139254858

Facility Contacts

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Evgeny Pokushalov, MD, PhD

Role: primary

+79139254858

Related Links

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http://meshalkin.ru

State Research Institute of Circulation Pathology Official Site

Other Identifiers

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BT_SVT

Identifier Type: -

Identifier Source: org_study_id

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