NCT05016921

Brief Summary

Open label study of transcutaneous magnetic stimulation targeting the stellate ganglion in patients with ventricular tachycardia

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
withdrawn

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

August 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

August 16, 2021

Last Update Submit

April 2, 2024

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

  • Ventricular Tachycardia

    Burden (number of episodes) of ventricular tachycardia

    0-72 hours after enrollment

Secondary Outcomes (2)

  • Non sustained ventricular tachycardia

    0-72 hours after enrollment

  • Discomfort

    Assessed immediately following stimulation

Study Arms (1)

Transcutaneous magnetic stimulation

EXPERIMENTAL

Transcutaneous magnetic stimulation targeting the stellate ganglion

Device: TcMS

Interventions

TcMSDEVICE

Transcutaneous magnetic stimulation targeting the stellate ganglion

Transcutaneous magnetic stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18years
  • Documented ventricular tachycardia within the preceding 72 hours

You may not qualify if:

  • Pregnancy
  • Implanted ventricular assist device
  • Metal implanted in heard or neck (except the mouth)
  • Implanted medication pumps
  • Cochlear implant
  • Implanted brain stimulator
  • Ocular implant
  • History of malignancy in the 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

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 23, 2021

Study Start

January 1, 2024

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)