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NCT05377216 Clinical Trial

Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation

Ventricular Tachycardia Clinical Trial

Official title:
Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05377216
Other study ID # 851066
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date September 1, 2022
Est. completion date July 1, 2027

Study information
Verified date October 2023
Source University of Pennsylvania
Contact Timothy Markman, MD
Phone 267-593-0103
Email timothy.markman@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date July 1, 2027
Est. primary completion date June 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Stellate Ganglion Block
Left sided percutaneous stellate ganglion block

Locations
Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ventricular Effective Refractory Period Change in Ventricular Effective Refractory Period at 600ms drive train (measured in milliseconds) 30 minutes following stellate ganglion block
Secondary Ventricular Arrhythmia Inducibility Induction of monomorphic ventricular arrhythmia (binary outcome) during ventricular programmed stimulation 30 minutes following stellate ganglion block
Secondary Neuropeptide Y Change in level of neuropeptide Y from baseline (measured in pg/mL) 30 minutes following stellate ganglion block
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