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Magnetic Stimulation to Treat VT Storm (STAR-VT)

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ClinicalTrials.gov Identifier: NCT04043312
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Device: Magstim SuperRapid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Control
Patients will receive one hour of sham stimulation.
Device: Magstim SuperRapid
Sham transcutaneous magnetic stimulation.

Experimental: Active
Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.
Device: Magstim SuperRapid
Transcutaneous magnetic stimulation targeting the left stellate ganglion.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Cardioversion - Incidence of ICD 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. Changes in ICD or pacemaker lead impedances [ Time Frame: Immediately following completion of the protocol ]
    Change in lead impedance (unit: Ohms) on device interrogation

  3. Changes in ICD or pacemaker lead thresholds [ Time Frame: Immediately following completion of the protocol ]
    Change in lead thresholds (unit: mV) on device interrogation

  4. Changes in ICD or pacemaker lead sensitivities [ Time Frame: Immediately following completion of the protocol ]
    Change in lead sensitivity (unit: mA) on device interrogation

  5. Local effect from stimulation - Incidence of local skin irritation or patient reported local discomfort on visual analog scale (1-10) [ Time Frame: Immediately following completion of the protocol ]
    Incidence of local skin irritation or patient reported local discomfort on visual analog scale (1-10)

  6. Antiarrhythmic drugs used post stimulation - Incidence of antiarrhythmic drug use post stimulation per inpatient medical record [ Time Frame: 72 hours following completion of the protocol ]
    Incidence of antiarrhythmic drug use post stimulation per inpatient medical record



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 malignancy in region of stimulation (neck)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043312


Contacts
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Contact: Timothy Markman, MD 2675930103 timothy.markman@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Timothy Markman, MD         
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04043312     History of Changes
Other Study ID Numbers: 833561
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes