Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation
1 other identifier
interventional
20
1 country
1
Brief Summary
Prospective cohort study evaluating the electrophysiologic and biochemical effects of stellate ganglion block in patients with ventricular tachycardia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Sep 2022
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
November 21, 2025
November 1, 2025
4.8 years
May 2, 2022
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 (2)
Ventricular Arrhythmia Inducibility
30 minutes following stellate ganglion block
Neuropeptide Y
30 minutes following stellate ganglion block
Study Arms (1)
Stellate ganglion block
EXPERIMENTALAll subjects will undergo stellate ganglion block during their VT ablation procedure
Interventions
Eligibility Criteria
You may qualify if:
- Planned catheter based VT ablation
- Age at least 18 years
You may not qualify if:
- Pregnancy
- Contraindication to SGB or VT ablation
- Hypersensitivity of local anesthetic of amide type
- Hemodynamic instability during the procedure prior to the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2022
First Posted
May 17, 2022
Study Start
September 1, 2022
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
November 21, 2025
Record last verified: 2025-11