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Botulinum Toxin Injection to Prevent VT Storm

M

Meshalkin Research Institute of Pathology of Circulation

Status and phase

Unknown
Phase 1

Conditions

VT Storm

Treatments

Drug: BT injection

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT02003027
BT_VT Storm

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

BT injection
Experimental group
Treatment:
Drug: BT injection

Trial contacts and locations

1

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Central trial contact

Evgeny Pokushalov, MD, PhD

Data sourced from clinicaltrials.gov

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