Magnetic Stimulation to Treat VT Storm (STAR-VT)

October 12, 2022 updated by: University of Pennsylvania

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Control
Patients will receive one hour of sham stimulation.
Device: Magstim SuperRapid
Transcutaneous magnetic stimulation targeting the left stellate ganglion.
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.
Device: Magstim SuperRapid
Sham transcutaneous magnetic stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24-hours following completion of the protocol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48-hours following completion of the protocol
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
Immediately following completion of the protocol
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
Immediately following completion of the protocol
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
Immediately following completion of the protocol
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.
Immediately following completion of the protocol
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
24 hours following completion of the protocol
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.
Immediately following completion of the stimulation
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.
Immediately following the completion of the stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 14, 2019

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

July 30, 2021

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (ACTUAL)

August 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 833561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ventricular Tachycardia

Clinical Trials on Magstim SuperRapid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe