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

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

Arrhythmia

Ventricular Tachycardia (VT)

Treatments

Other: Vagus Nerve Stimulation (VNS)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04359004

19-001929

OT2OD028201 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No 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
Inability to give informed consent.