TcMS to Treat Ventricular Tachycardia | NCT05016921

Studies
TcMS to Treat Ventricular Tachycardia

NCT05016921

Sponsor

University of Pennsylvania

Status

Withdrawn

Last Update Posted

Apr 4, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Ventricular Tachycardia

Interventions

TcMS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Alternate study pursued

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Jan 1, 2024Actual

Completion Date

Jan 1, 2024Estimated

First Submitted Date

Aug 16, 2021

First Submission Date that Met QC Criteria

Aug 16, 2021

First Posted Date

Aug 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2024

Last Update Posted Date

Apr 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transcutaneous magnetic stimulation	Experimental	Transcutaneous magnetic stimulation targeting the stellate ganglion	Device: TcMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TcMS	Device	Transcutaneous magnetic stimulation targeting the stellate ganglion	Transcutaneous magnetic stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ventricular Tachycardia	Burden (number of episodes) of ventricular tachycardia	0-72 hours after enrollment

Secondary Outcomes

Measure	Description	Time Frame
Non sustained ventricular tachycardia	Burden (number of episodes) of ventricular tachycardia	0-72 hours after enrollment
Discomfort	Discomfort experienced during stimulation (on scale of 0-10) reported by patient

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017180	Tachycardia, Ventricular

Ancestor Terms

ID	Term
D013610	Tachycardia
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided