Botulinum Toxin Injection to Prevent VT Storm | NCT02003027

Studies
Botulinum Toxin Injection to Prevent VT Storm

NCT02003027

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Status

Unknown status

Last Update Posted

Sep 23, 2015Estimated

Enrollment

15Estimated

Phase

Phase 1

Conditions

VT Storm

Interventions

BT injection

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Dec 2, 2013

First Submission Date that Met QC Criteria

Dec 2, 2013

First Posted Date

Dec 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 episodes of VT Storm.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Label	Type	Description	Intervention Names
BT injection	Experimental		Drug: BT injection

Name	Type	Description	Arm Group Labels	Other Names
BT injection	Drug		BT injection

Measure	Description	Time Frame
number of episodes of VT Storm		1 year

Measure	Description	Time Frame
serious adverse events		1 year

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Evgeny Pokushalov, MD, PhD	Contact	+79139254858		e.pokushalov@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
State Research Institute of Circulation Pathology	Recruiting	Novosibirsk		630055	Russia

References Module

Citations

Not provided