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OpenTrials
Completed

NCT Number: NCT04043312

Magnetic Stimulation to Treat VT Storm

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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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Magstim SuperRapid

Device

Transcutaneous magnetic stimulation targeting the left stellate ganglion.

Primary outcomes

  1. Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring

    Time frame: 24-hours following completion of the protocol

    Incidence of ventricular tachycardia on inpatient telemetry monitoring

Secondary outcomes

  1. Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry

    Time frame: 48-hours following completion of the protocol

    Incidence of ICD or external defibrillation following stimulation on device interrogation or telemetry

  2. Number of Patients With Changes in ICD or Pacemaker Lead Impedances

    Time frame: Immediately following completion of the protocol

    Number of patients with changes in lead impedance (unit: Ohms) on device interrogation

  3. Number of Patients With Changes in ICD or Pacemaker Lead Thresholds

    Time frame: Immediately following completion of the protocol

    Number of patients with changes in lead thresholds (unit: mV) on device interrogation

  4. Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities

    Time frame: Immediately following completion of the protocol

    Number of patient with changes in lead sensitivity (unit: mA) on device interrogation

  5. Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10)

    Time frame: 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.

  6. Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record

    Time frame: 24 hours following completion of the protocol

    Incidence of antiarrhythmic drug use post stimulation per inpatient medical record

  7. Number of Patients With Changes in ECG Parameters

    Time frame: Immediately following completion of the stimulation

    Number of patients with any clinical significant change in PR, QRS, or QT interval before and after stimulation.

  8. Number of Patients With Changes in Vital Signs

    Time frame: Immediately following the completion of the stimulation

    Number of patients with clinical significant change in heart rate or blood pressure during the procedure.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: STAR-VT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2019
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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