Botulinum Toxin Injection to Prevent Ventricular Arrhythmias

NCT ID: NCT02003001

Last Updated: 2015-09-25

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

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-12-31

Brief Summary

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The aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in left ventricle for preventing ventricular arrhythmias.

Detailed Description

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Conditions

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Symptomatic Ventricular Asystolia Ventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BT injection

Group Type EXPERIMENTAL

Botulinum Toxin

Intervention Type DRUG

Interventions

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Botulinum Toxin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* symptomatic ventricular arrhythmias
* drug-resistance
* unsuccessful one or more ablation procedure with future unreasonable tries

Exclusion Criteria

* Previous heart surgery and AF ablation procedure
* Emergency CABG
* Unstable angina or heart failure
* Use antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone)
* Requiring concomitant valve surgery
* Left ventricle ejection fraction \<35%
* Unwillingness to participate
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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State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status RECRUITING

Countries

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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

Related Links

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http://meshalkin.ru

State Research Institute of Circulation Pathology Official Site

Other Identifiers

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BT_VA

Identifier Type: -

Identifier Source: org_study_id

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