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TcMS to Treat Ventricular Tachycardia

Primary Purpose

Ventricular Tachycardia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TcMS
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

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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcutaneous magnetic stimulation

Arm Description

Transcutaneous magnetic stimulation targeting the stellate ganglion

Outcomes

Primary Outcome Measures

Ventricular Tachycardia
Burden (number of episodes) of ventricular tachycardia

Secondary Outcome Measures

Non sustained ventricular tachycardia
Burden (number of episodes) of ventricular tachycardia
Discomfort
Discomfort experienced during stimulation (on scale of 0-10) reported by patient

Full Information

First Posted
August 16, 2021
Last Updated
July 17, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05016921
Brief Title
TcMS to Treat Ventricular Tachycardia
Official Title
Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2024 (Anticipated)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

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

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous magnetic stimulation
Arm Type
Experimental
Arm Description
Transcutaneous magnetic stimulation targeting the stellate ganglion
Intervention Type
Device
Intervention Name(s)
TcMS
Intervention Description
Transcutaneous magnetic stimulation targeting the stellate ganglion
Primary Outcome Measure Information:
Title
Ventricular Tachycardia
Description
Burden (number of episodes) of ventricular tachycardia
Time Frame
0-72 hours after enrollment
Secondary Outcome Measure Information:
Title
Non sustained ventricular tachycardia
Description
Burden (number of episodes) of ventricular tachycardia
Time Frame
0-72 hours after enrollment
Title
Discomfort
Description
Discomfort experienced during stimulation (on scale of 0-10) reported by patient
Time Frame
Assessed immediately following stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18years Documented ventricular tachycardia within the preceding 72 hours Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Markman, MD
Phone
2675930103
Email
timothy.markman@pennmedicine.upenn.edu
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

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TcMS to Treat Ventricular Tachycardia

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