NCT04043312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

August 14, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 5, 2022

Completed
Last Updated

November 8, 2022

Status Verified

October 1, 2022

Enrollment Period

1.9 years

First QC Date

July 25, 2019

Results QC Date

April 4, 2022

Last Update Submit

October 12, 2022

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

  • Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring

    Incidence of ventricular tachycardia on inpatient telemetry monitoring

    24-hours following completion of the protocol

Secondary Outcomes (8)

  • Cardioversion - Incidence of ICD Therapies 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

    Immediately following completion of the protocol

  • Number of Patients With Changes in ICD or Pacemaker Lead Thresholds

    Immediately following completion of the protocol

  • Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities

    Immediately following completion of the protocol

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

    Immediately following completion of the protocol

  • +3 more secondary outcomes

Study Arms (2)

Control

SHAM COMPARATOR

Patients will receive one hour of sham stimulation.

Device: Magstim SuperRapid

Active

EXPERIMENTAL

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

Device: Magstim SuperRapid

Interventions

Magstim SuperRapidDEVICE

Transcutaneous magnetic stimulation targeting the left stellate ganglion.

Active

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 3 episodes of VT in 24 hours

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 35171197DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Timothy Markman
Organization
Hospital of the University of Pennsylvania
timothy.markman@uphs.upenn.edu
267-593-0103

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2019

First Posted

August 2, 2019

Study Start

August 14, 2019

Primary Completion

June 30, 2021

Study Completion

July 30, 2021

Last Updated

November 8, 2022

Results First Posted

July 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)