Magnetic Stimulation to Treat VT Storm

Study Overview
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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.

Official Title
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A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Device: Magstim SuperRapid
* Device: Magstim SuperRapid


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Patients will receive one hour of sham stimulation. | Device: Magstim SuperRapid<br>* Sham transcutaneous magnetic stimulation.<br>|
| Experimental: Active<br>Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. | Device: Magstim SuperRapid<br>* Transcutaneous magnetic stimulation targeting the left stellate ganglion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring | Incidence of ventricular tachycardia on inpatient telemetry monitoring | 24-hours following completion of the protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry | Incidence of ICD or external defibrillation following stimulation on device interrogation or telemetry | 48-hours following completion of the protocol | 
| Number of Patients With Changes in ICD or Pacemaker Lead Impedances | Number of patients with changes in lead impedance (unit: Ohms) on device interrogation | Immediately following completion of the protocol | 
| Number of Patients With Changes in ICD or Pacemaker Lead Thresholds | Number of patients with changes in lead thresholds (unit: mV) on device interrogation | Immediately following completion of the protocol | 
| Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities | Number of patient with changes in lead sensitivity (unit: mA) on device interrogation | Immediately following completion of the protocol | 
| Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10) | Scores on a visual analog scale (0-10) of discomfort - 0= no discomfort, 1 = minimal discomfort, 10 = most severe discomfort imaginable. | Immediately following completion of the protocol | 
| Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record | Incidence of antiarrhythmic drug use post stimulation per inpatient medical record | 24 hours following completion of the protocol | 
| Number of Patients With Changes in ECG Parameters | Number of patients with any clinical significant change in PR, QRS, or QT interval before and after stimulation. | Immediately following completion of the stimulation | 
| Number of Patients With Changes in Vital Signs | Number of patients with clinical significant change in heart rate or blood pressure during the procedure. | Immediately following the completion of the stimulation |