Randomized Assessment of TcMS for VT Storm

Study Overview
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Brief Summary
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Three-arm randomized clinical trial comparing two strategies of TcMS to sham stimulation in patients with VT storm. The hypothesis of the study is that TcMS will reduce the burden of VT in the 24 hours after randomization compared to sham stimulation and that TcMS with theta burst stimulation (TBS) will be more effective at reducing VT burden than low frequency TcMS.

Official Title
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Randomized Assessment of the Efficacy of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Device: Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥3 episodes of sustained VT or appropriate ICD therapies within 24 hours despite the use of at least one antiarrhythmic drug Exclusion Criteria: Plan for catheter ablation of VT in the next 24 hours Pregnancy Contraindication to TcMS (i.e. implantable ventricular assist device, metal implanted in the head or neck [except the mouth], implanted medication pumps, cochlear implant, implanted brain stimulator, ocular implant, history of malignancy in the neck)

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Placebo Comparator: Sham Stimulation<br>With the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output. | Device: Magnetic Stimulation<br>* Transcutaneous Magnetic Stimulation<br>|
| Active Comparator: Low Frequency TcMS<br>With the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion. | Device: Magnetic Stimulation<br>* Transcutaneous Magnetic Stimulation<br>|
| Active Comparator: Theta Burst Stimulation TcMS<br>With the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion. | Device: Magnetic Stimulation<br>* Transcutaneous Magnetic Stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VT Burden (24 hours) | Number of episodes of sustained ventricular tachycardia | 24 hours after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VT burden (72 hours) | Number of episodes of sustained ventricular tachycardia | 72 hours after randomization | 
| Freedom from VT | Freedom from sustained VT | 24 hours after randomization | 
| Blood Pressure | Change in mean arterial blood pressure | Immediately before and after stimulation | 
| Heart Rate | Change in heart rate | Immediately before and after stimulation | 
| Pain | Pain at site of stimulation (0-10 scale) | Immediately after stimulation | 
| Lead sensing | Change in implantable device lead sensing | Immediately before and after stimulation | 
| Lead threshold | Change in implantable device lead pacing threshold | Immediately before and after stimulation | 
| Lead impedance | Change in implantable device lead pacing impedance | Immediately before and after stimulation |