Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05377216
Collaborator
(none)
20
1
58

Study Details

Study Description

Brief Summary

Prospective cohort study evaluating the electrophysiologic and biochemical effects of stellate ganglion block in patients with ventricular tachycardia.

Condition or Disease Intervention/Treatment Phase
  • Drug: Stellate Ganglion Block
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2027
Anticipated Study Completion Date :
Jul 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stellate ganglion block

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

Drug: Stellate Ganglion Block
Left sided percutaneous stellate ganglion block

Outcome Measures

Primary Outcome Measures

  1. Ventricular Effective Refractory Period [30 minutes following stellate ganglion block]

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

Secondary Outcome Measures

  1. Ventricular Arrhythmia Inducibility [30 minutes following stellate ganglion block]

    Induction of monomorphic ventricular arrhythmia (binary outcome) during ventricular programmed stimulation

  2. Neuropeptide Y [30 minutes following stellate ganglion block]

    Change in level of neuropeptide Y from baseline (measured in pg/mL)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05377216
Other Study ID Numbers:
  • 851066
First Posted:
May 17, 2022
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022