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Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation

Primary Purpose

Ventricular Tachycardia

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stellate Ganglion Block
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ventricular Tachycardia

Eligibility Criteria

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

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

Sites / Locations

  • Hospital of the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stellate ganglion block

Arm Description

All subjects will undergo stellate ganglion block during their VT ablation procedure

Outcomes

Primary Outcome Measures

Ventricular Effective Refractory Period
Change in Ventricular Effective Refractory Period at 600ms drive train (measured in milliseconds)

Secondary Outcome Measures

Ventricular Arrhythmia Inducibility
Induction of monomorphic ventricular arrhythmia (binary outcome) during ventricular programmed stimulation
Neuropeptide Y
Change in level of neuropeptide Y from baseline (measured in pg/mL)

Full Information

First Posted
May 2, 2022
Last Updated
October 23, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05377216
Brief Title
Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation
Official Title
Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
July 1, 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
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective cohort study evaluating the electrophysiologic and biochemical effects of stellate ganglion block 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
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stellate ganglion block
Arm Type
Experimental
Arm Description
All subjects will undergo stellate ganglion block during their VT ablation procedure
Intervention Type
Drug
Intervention Name(s)
Stellate Ganglion Block
Intervention Description
Left sided percutaneous stellate ganglion block
Primary Outcome Measure Information:
Title
Ventricular Effective Refractory Period
Description
Change in Ventricular Effective Refractory Period at 600ms drive train (measured in milliseconds)
Time Frame
30 minutes following stellate ganglion block
Secondary Outcome Measure Information:
Title
Ventricular Arrhythmia Inducibility
Description
Induction of monomorphic ventricular arrhythmia (binary outcome) during ventricular programmed stimulation
Time Frame
30 minutes following stellate ganglion block
Title
Neuropeptide Y
Description
Change in level of neuropeptide Y from baseline (measured in pg/mL)
Time Frame
30 minutes following stellate ganglion block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Markman, MD
Phone
267-593-0103
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Markman, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation

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