Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study

Not Applicable

Recruiting

• Conditions: Neuromodulation
• Interventions: Device: Auricular Vagal Nerve Stimulation

• Registration Number: NCT05350150
• Lead Sponsor: Northwell Health

Brief Summary

The Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study is a single center, pilot, prospective study that aims at evaluating the effects of auricular vagus nerve stimulation (aVNS) on the human cardiac conduction system.

Detailed Description

The Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study is a single center, pilot, prospective study that aims at evaluating the effects of auricular vagus nerve stimulation (aVNS) on the human cardiac conduction system. In this study, we will enroll 10 healthy individuals presenting to the electrophysiology laboratory for an electrophysiological study (EPS). Patients will undergo a standard EPS with 4 catheters (coronary sinus catheter, His catheter, right ventricular catheter, and right atrial catheter). Following the standard EPS, patients will be hooked up a Parasym device to provide transcutaneous electrical stimulation to the auricular branch of the vagus nerve.

Study Timeline

• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Study Start: 2022-08-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Primary indication for EPS for the evaluation of cardiac conduction system or supraventricular tachycardia.

Exclusion Criteria

• Previous EPS with ablation
• Previous failed ablation
• Known conduction system disease, right or left bundle branch block on EKG
• Pregnant women
• History of postural orthostatic tachycardia syndrome
• Patients who have had prior cervical vagotomy
• Patients with skin on the tragus that is broken or cracked
• Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years) and patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients with an active implantable medical device, such as a cardiac pacemaker, hearing aid implant, or any implanted metallic, implanted vagus nerve stimulator or electronic device.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Auricular Vagal Nerve Stimulation	Auricular Vagal Nerve Stimulation	Patients will undergo a standard EPS with 4 catheters. Following the standard EPS, patients will be hooked up a Parasym device to provide transcutaneous electrical stimulation to the auricular branch of the vagus nerve, EPS will be repeated.

Primary Outcome Measures

Name	Time	Method
Change in Sinus Cycle Length	Pre procedure/procedure	Sinus cycle length (msec)
Change in QRS Duration	Pre procedure/procedure	QRS Duration (msec)
Change in AV Node Wenckebach Cycle Length	Pre procedure/procedure	AV Node Wenckebach Cycle Length (msec)
Change in AV Node Effective Refractory Period	Pre procedure/procedure	AV Node Effective Refractory Period (ERP) (msec)
Change in Right Ventricular Effective Refractory Period ERP	Pre procedure/procedure	Right Ventricular Effective Refractory Period ERP (msec)
Supraventricular Tachycardia induction	Pre procedure/procedure	Supraventricular Tachycardia induction
Change in A-H Interval	Pre procedure/procedure	A-H Interval (msec)
Change in H-V Interval	Pre procedure/procedure	H-V interval (msec)
Change in Atrial Effective Refractory Period	Pre procedure/procedure	Atrial Effective Refractory Period ERP (msec)
Change in Accessory Pathway Anterograde Effective Refractory Period ERP	Pre procedure/procedure	Accessory Pathway Anterograde Effective Refractory Period (msec)
Change in QT Duration	Pre procedure/procedure	QT Duration (msec)
Change in Sinus Node Recovery Time	Pre procedure/procedure	Sinus Node Recovery Time (msec)
Change in Accessory Pathway Retrograde Effective Refractory Period ERP	Pre procedure/procedure	Accessory Pathway Anterograde Effective Refractory Period (msec)
Change in retrograde block cycle length	Pre procedure/procedure	Retrograde Block Cycle Length (msec)
Supraventricular Tachycardia Termination	Pre procedure/procedure	Supraventricular Tachycardia Termination

Trial Locations

Locations (1)

Kristie Coleman; 🇺🇸 New York, New York, United States