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Magnetic Stimulation to Treat VT Storm (STAR-VT)

Primary Purpose

Ventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magstim SuperRapid
Magstim SuperRapid
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Active

Arm Description

Patients will receive one hour of sham stimulation.

Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.

Outcomes

Primary Outcome Measures

Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring
Incidence of ventricular tachycardia on inpatient telemetry monitoring

Secondary Outcome Measures

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
Number of Patients With Changes in ICD or Pacemaker Lead Impedances
Number of patients with changes in lead impedance (unit: Ohms) on device interrogation
Number of Patients With Changes in ICD or Pacemaker Lead Thresholds
Number of patients with changes in lead thresholds (unit: mV) on device interrogation
Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities
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)
Scores on a visual analog scale (0-10) of discomfort - 0= no discomfort, 1 = minimal discomfort, 10 = most severe discomfort imaginable.
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
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.
Number of Patients With Changes in Vital Signs
Number of patients with clinical significant change in heart rate or blood pressure during the procedure.

Full Information

First Posted
July 25, 2019
Last Updated
October 12, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04043312
Brief Title
Magnetic Stimulation to Treat VT Storm
Acronym
STAR-VT
Official Title
A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Patients will receive one hour of sham stimulation.
Arm Title
Active
Arm Type
Experimental
Arm Description
Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.
Intervention Type
Device
Intervention Name(s)
Magstim SuperRapid
Intervention Description
Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Intervention Type
Device
Intervention Name(s)
Magstim SuperRapid
Intervention Description
Sham transcutaneous magnetic stimulation.
Primary Outcome Measure Information:
Title
Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring
Description
Incidence of ventricular tachycardia on inpatient telemetry monitoring
Time Frame
24-hours following completion of the protocol
Secondary Outcome Measure Information:
Title
Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry
Description
Incidence of ICD or external defibrillation following stimulation on device interrogation or telemetry
Time Frame
48-hours following completion of the protocol
Title
Number of Patients With Changes in ICD or Pacemaker Lead Impedances
Description
Number of patients with changes in lead impedance (unit: Ohms) on device interrogation
Time Frame
Immediately following completion of the protocol
Title
Number of Patients With Changes in ICD or Pacemaker Lead Thresholds
Description
Number of patients with changes in lead thresholds (unit: mV) on device interrogation
Time Frame
Immediately following completion of the protocol
Title
Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities
Description
Number of patient with changes in lead sensitivity (unit: mA) on device interrogation
Time Frame
Immediately following completion of the protocol
Title
Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10)
Description
Scores on a visual analog scale (0-10) of discomfort - 0= no discomfort, 1 = minimal discomfort, 10 = most severe discomfort imaginable.
Time Frame
Immediately following completion of the protocol
Title
Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record
Description
Incidence of antiarrhythmic drug use post stimulation per inpatient medical record
Time Frame
24 hours following completion of the protocol
Title
Number of Patients With Changes in ECG Parameters
Description
Number of patients with any clinical significant change in PR, QRS, or QT interval before and after stimulation.
Time Frame
Immediately following completion of the stimulation
Title
Number of Patients With Changes in Vital Signs
Description
Number of patients with clinical significant change in heart rate or blood pressure during the procedure.
Time Frame
Immediately following the completion of the stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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 active malignancy in region of stimulation (neck)
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35171197
Citation
Markman TM, Pothineni NVK, Zghaib T, Smietana J, McBride D, Amankwah NA, Linn KA, Kumareswaran R, Hyman M, Arkles J, Santangeli P, Schaller RD, Supple GE, Frankel DS, Deo R, Lin D, Riley MP, Epstein AE, Callans DJ, Marchlinski FE, Hamilton R, Nazarian S. Effect of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm: A Randomized Clinical Trial. JAMA Cardiol. 2022 Apr 1;7(4):445-449. doi: 10.1001/jamacardio.2021.6000.
Results Reference
derived

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Magnetic Stimulation to Treat VT Storm

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