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A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation | Clinical Trials | Clareo Health

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A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation

A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing Ventricular Tachycardia (VT) Ablation

NCT04359004•University of California, Los Angeles

View on ClinicalTrials.gov

Summary

Vagus nerve stimulation (VNS) has been shown to be beneficial in multiple studies including heart failure. The goal of this clinical investigation is to gain additional information about how vagus nerve stimulation relates to abnormal heart rhythms. The outcomes of this study will help researchers design new therapies for patients that have complex and life-threatening ventricular arrhythmias.

Detailed Description

This study is a non-randomized, prospective study in 6 patients with scar mediated ventricular arrhythmias who are scheduled to undergo a catheter ablation procedure. The study will last up to 30 minutes in the cardiac electrophysiology lab. Cervical VNS is performed percutaneously through the internal jugular vein during the patient's routine ventricular tachycardia (VT) ablation procedure.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Presence of structural heart disease as defined as EF ≤ 50% or presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
•Age \> 18 years old
•Underlying sinus rhythm with heart rate \> 50 bpm.
•Provision of signed/dated informed consent and stated willingness to comply with all study procedures

Exclusion Criteria

•Active ongoing cardiac ischemia as assessed by: ECG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (\>70%), or stress testing. (Note: positive troponin assay due to Internal Cardiac Defibrillator (ICD) shocks is not an exclusion criterion).
•Status post orthotopic heart transplantation
•Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
•Unable or unwilling to comply with protocol requirements.
•Known channelopathy such as long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic VT.
•Known peripheral neuropathy or history of autonomic dysfunction due to non-cardiac causes.
•New York Heart Association Class IV heart failure or use of current vasopressor medications
•Incessant VT
•Persistent atrial fibrillation
•Frequent premature atrial or ventricular contractions
+1 more criteria

Locations (1)

UCLA Health

Los Angeles, California, United States

Key Dates

Start Date

December 8, 2020

Primary Completion Date

June 30, 2023

Completion Date

October 30, 2023

Last Updated

November 13, 2023

Enrollment

ACTUAL participants

Conditions

ArrhythmiaVentricular Tachycardia (VT)

Interventions

Vagus Nerve Stimulation (VNS)

OTHER

CMR-Based Prognostic Study in Patients With Cardiac Implantable Electronic Devices

NCT07336225

Arrhythmias

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RECRUITING

Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention

NCT00733590

Heart Failure, CongestiveDeath, Sudden, Cardiac+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation

Inclusion Criteria

Exclusion Criteria

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