Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Kalyanam Shivkumar, MD, PhD (ucla)
Photo of Kalyanam Shivkumar
Kalyanam Shivkumar

Description

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.

Official Title

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

Details

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.

Keywords

Arrhythmia Ventricular Tachycardia (VT) Vagus Nerve Stimulation (VNS) Activation Recovery Interval (ARI) Arrhythmias, Cardiac Tachycardia Tachycardia, Ventricular

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Location

  • UCLA Health accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04359004
Study Type
Interventional
Last Updated