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

Sponsor

University of California, Los Angeles (Other)

Overall Status

Recruiting

CT.gov ID

NCT04359004

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

29.7

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia Ventricular Tachycardia (VT)	Other: Vagus Nerve Stimulation (VNS)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Dec 8, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.