Magnetic Stimulation to Treat VT Storm

Not Applicable

Completed

• Conditions: Ventricular Tachycardia
• Interventions: Device: Magstim SuperRapid

• Registration Number: NCT04043312
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-02
• Study Start: 2019-08-14
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-30
• Results First Submitted: 2022-04-04
• Results First Submitted QC: 2022-07-01
• Results First Posted: 2022-07-05
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• ≥ 3 episodes of VT in 24 hours

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Magstim SuperRapid	Patients will receive one hour of sham stimulation.
Active	Magstim SuperRapid	Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.

Primary Outcome Measures

Name	Time	Method
Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring	24-hours following completion of the protocol	Incidence of ventricular tachycardia on inpatient telemetry monitoring

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States