Magnetic Stimulation to Treat VT Storm

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2021-07-30

Brief Summary

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Ventricular Tachycardia storm is a medical emergency characterized by three or more episodes of ventricular arrhythmia within 24 hours and associated with a significantly increased mortality and massive health resource utilization. Several therapies are utilized including sympathetic blockade (through deep sedation and beta blockers), antiarrhythmic drugs, implantable cardioverter defibrillator (ICD) reprograming where applicable, and catheter ablation. Despite standard intervention, mortality rates remain high and additional therapeutic options are actively being investigated.

The overall objective of this proposal is to investigate whether transcutaneous magnetic stimulation designed to inhibit the left stellate ganglion can be used in this population. This is a single-center, randomized, sham-controlled trial to assess the efficacy of transcutaneous magnetic stimulation of the left stellate ganglion to treat patients with ventricular tachycardia storm.

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Detailed Description

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Conditions

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Ventricular Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control

Patients will receive one hour of sham stimulation.

Group Type SHAM_COMPARATOR

Magstim SuperRapid

Intervention Type DEVICE

Sham transcutaneous magnetic stimulation.

Active

Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.

Group Type EXPERIMENTAL

Magstim SuperRapid

Intervention Type DEVICE

Transcutaneous magnetic stimulation targeting the left stellate ganglion.

Interventions

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Magstim SuperRapid

Transcutaneous magnetic stimulation targeting the left stellate ganglion.

Intervention Type DEVICE

Magstim SuperRapid

Sham transcutaneous magnetic stimulation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ≥ 3 episodes of VT in 24 hours

Exclusion Criteria

* Pregnancy
* Implanted ventricular assist device
* Metal implanted in head or neck (except the mouth)
* Implanted medication pumps
* Cochlear implant
* Implanted brain stimulator
* Ocular implant
* History of active malignancy in region of stimulation (neck)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No