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Botulinum Toxin Injection to Prevent Ventricular Arrhythmias

Primary Purpose

Symptomatic Ventricular Asystolia, Ventricular Tachycardia

Status
Unknown status
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Botulinum Toxin
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Ventricular Asystolia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BT injection

Arm Description

Outcomes

Primary Outcome Measures

freedom of ventricular arrhythmias

Secondary Outcome Measures

serious adverse events
time to recurrence of ventricular arrhythmias

Full Information

First Posted
December 2, 2013
Last Updated
September 24, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02003001
Brief Title
Botulinum Toxin Injection to Prevent Ventricular Arrhythmias
Official Title
Endomyocardial Botulinum Toxin Injection Can Prevent Ventricular Arrhythmias: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Ventricular Asystolia, Ventricular Tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BT injection
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin
Primary Outcome Measure Information:
Title
freedom of ventricular arrhythmias
Time Frame
1 year
Secondary Outcome Measure Information:
Title
serious adverse events
Time Frame
1 year
Title
time to recurrence of ventricular arrhythmias
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evgeny Pokushalov, MD, PhD
Phone
+79139254858
Email
e.pokushalov@gmail.com
Facility Information:
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD

12. IPD Sharing Statement

Links:
URL
http://meshalkin.ru
Description
State Research Institute of Circulation Pathology Official Site

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Botulinum Toxin Injection to Prevent Ventricular Arrhythmias

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