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TcMS to Treat Ventricular Tachycardia

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ClinicalTrials.gov Identifier: NCT05016921
Recruitment Status : Not yet recruiting
First Posted : August 23, 2021
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Device: TcMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transcutaneous magnetic stimulation
Transcutaneous magnetic stimulation targeting the stellate ganglion
Device: TcMS
Transcutaneous magnetic stimulation targeting the stellate ganglion




Primary Outcome Measures :
  1. Ventricular Tachycardia [ Time Frame: 0-72 hours after enrollment ]
    Burden (number of episodes) of ventricular tachycardia


Secondary Outcome Measures :
  1. Non sustained ventricular tachycardia [ Time Frame: 0-72 hours after enrollment ]
    Burden (number of episodes) of ventricular tachycardia

  2. Discomfort [ Time Frame: Assessed immediately following stimulation ]
    Discomfort experienced during stimulation (on scale of 0-10) reported by patient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05016921


Contacts
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Contact: Timothy Markman, MD 2675930103 timothy.markman@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT05016921    
Other Study ID Numbers: 849193
First Posted: August 23, 2021    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes