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

Completed · Not applicable

Conditions studied: Arrhythmia, Ventricular Tachycardia (VT)

In brief

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.

Key facts

Study ID

NCT04359004

Run by

University of California, Los Angeles

People needed

5

Starts

2020-12-08

Expected to finish

2023-10-30

Last updated by the study team

2023-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UCLA Health — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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