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

About

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.

Primary Purpose
Basic Science
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.

Join this Trial

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Study Stats
Protocol No.
19-001929
Category
Cardiology
Contact
Julie Sorg
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04359004
For detailed technical eligibility, visit ClinicalTrials.gov.