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

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

Study Overview

• Status: Completed
• Conditions: Arrhythmia; Ventricular Tachycardia (VT)
• Intervention / Treatment: Other: Vagus Nerve Stimulation (VNS)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change in ventricular action potential duration during stimulation compared to baseline in msec	Up to 30 minutes or completion of the vagus nerve stimulation

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in blood pressure during stimulation compared to baseline in mmHg.	Up to 30 minutes or completion of the vagus nerve stimulation
The change in heart rate during stimulation compared to baseline in beats per minute	Up to 30 minutes or completion of the vagus nerve stimulation

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Kalyanam Shivkumar, MD, PhD, University of California, Los Angeles

Publications and helpful links

General Publications

• Vaseghi M, Salavatian S, Rajendran PS, Yagishita D, Woodward WR, Hamon D, Yamakawa K, Irie T, Habecker BA, Shivkumar K. Parasympathetic dysfunction and antiarrhythmic effect of vagal nerve stimulation following myocardial infarction. JCI Insight. 2017 Aug 17;2(16):e86715. doi: 10.1172/jci.insight.86715. eCollection 2017 Aug 17.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Arrhythmia; Vagus Nerve Stimulation (VNS); Activation Recovery Interval (ARI)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 19-001929; OT2OD028201 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No