Botulinum Toxin Injection to Prevent VT Storm

NCT ID: NCT02003027

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

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-01-31

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 episodes of VT Storm.

Detailed Description

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Conditions

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VT Storm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BT injection

Group Type EXPERIMENTAL

BT injection

Intervention Type DRUG

Interventions

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BT injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 3 or more episodes of ventricular tachycardia within 24 hours

Exclusion Criteria

* Failure to provide informed consent.
* Non-cardiac illness with a life expectancy of less than 3 year
* Non-cardiac illness imposing substantial operative mortality
* Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device
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

+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_VT Storm

Identifier Type: -

Identifier Source: org_study_id

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