Characterization of Cardiac Electrophysiological Effects... | NCT05377216

Studies
Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation

NCT05377216

Sponsor

University of Pennsylvania

Status

Recruiting

Last Update Posted

Nov 21, 2025Actual

Enrollment

20Estimated

Phase

Early Phase 1

Conditions

Ventricular Tachycardia

Interventions

Stellate Ganglion Block

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

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Jul 1, 2027Estimated

Completion Date

Jul 1, 2027Estimated

First Submitted Date

May 2, 2022

First Submission Date that Met QC Criteria

May 11, 2022

First Posted Date

May 17, 2022Actual

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

Nov 20, 2025

Last Update Posted Date

Nov 21, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

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

Prospective cohort study evaluating the electrophysiologic and biochemical effects of stellate ganglion block 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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stellate ganglion block	Experimental	All subjects will undergo stellate ganglion block during their VT ablation procedure	Drug: Stellate Ganglion Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stellate Ganglion Block	Drug	Left sided percutaneous stellate ganglion block	Stellate ganglion block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ventricular Effective Refractory Period	Change in Ventricular Effective Refractory Period at 600ms drive train (measured in milliseconds)	30 minutes following stellate ganglion block

Secondary Outcomes

Measure	Description	Time Frame
Ventricular Arrhythmia Inducibility	Induction of monomorphic ventricular arrhythmia (binary outcome) during ventricular programmed stimulation	30 minutes following stellate ganglion block
Neuropeptide Y

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Planned catheter based VT ablation
Age at least 18 years

Exclusion Criteria:

Pregnancy
Contraindication to SGB or VT ablation
Hypersensitivity of local anesthetic of amide type
Hemodynamic instability during the procedure prior to the study protocol

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

Name	Role	Phone	Extension	Email
Timothy Markman, MD	Contact	267-593-0103		timothy.markman@pennmedicine.upenn.edu

Overall Officials

Not provided

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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