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

Not Applicable

Completed

• Conditions: Arrhythmia; Ventricular Tachycardia (VT)

• Registration Number: NCT04359004
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-24
• Study Start: 2020-12-08
• Primary Completion: 2023-06-30
• Study Completion: 2023-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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
• Inability to give informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The change in ventricular action potential duration during stimulation compared to baseline in msec	Up to 30 minutes or completion of the vagus nerve stimulation

Secondary Outcome Measures

Name	Time	Method
The change in blood pressure during stimulation compared to baseline in mmHg.	Up to 30 minutes or completion of the vagus nerve stimulation
The change in heart rate during stimulation compared to baseline in beats per minute	Up to 30 minutes or completion of the vagus nerve stimulation

Trial Locations

Locations (1)

UCLA Health; 🇺🇸 Los Angeles, California, United States