Skip to main content
OpenTrials
Completed

NCT Number: NCT04359004

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Health

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vagus Nerve Stimulation (VNS)

Other

Vagus Nerve Stimulation (VNS) will be performed percutaneously through the internal jugular vein during the patient's routine VT ablation procedure. The nerve will be stimulated using standard pacing systems used for clinical purposes. A series of stimulation frequencies and pulse widths will be used to define optimal effects and 'dosing'. Activation recovery interval (ARI) will be measured from the unipolar electrograms. In addition, heart rate and blood pressure responses will be continuously recorded.

Primary outcomes

  1. The change in ventricular action potential duration during stimulation compared to baseline in msec

    Time frame: Up to 30 minutes or completion of the vagus nerve stimulation

Secondary outcomes

  1. The change in blood pressure during stimulation compared to baseline in mmHg.

    Time frame: Up to 30 minutes or completion of the vagus nerve stimulation

  2. The change in heart rate during stimulation compared to baseline in beats per minute

    Time frame: Up to 30 minutes or completion of the vagus nerve stimulation

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2020
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.