Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study

NCT05350150 | Active Not Recruiting FDA Device

• 1 other identifier: 21-1109
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromodulation

Outcome Measures

Primary Outcomes (15)

• Change in Sinus Cycle Length

  Sinus cycle length (msec)

  Pre procedure/procedure

• Change in A-H Interval

  A-H Interval (msec)

  Pre procedure/procedure

• Change in H-V Interval

  H-V interval (msec)

  Pre procedure/procedure

• Change in QRS Duration

  QRS Duration (msec)

  Pre procedure/procedure

• Change in QT Duration

  QT Duration (msec)

  Pre procedure/procedure

• Change in Sinus Node Recovery Time

  Sinus Node Recovery Time (msec)

  Pre procedure/procedure

• Change in AV Node Wenckebach Cycle Length

  AV Node Wenckebach Cycle Length (msec)

  Pre procedure/procedure

• Change in AV Node Effective Refractory Period

  AV Node Effective Refractory Period (ERP) (msec)

  Pre procedure/procedure

• Change in Atrial Effective Refractory Period

  Atrial Effective Refractory Period ERP (msec)

  Pre procedure/procedure

• Change in Right Ventricular Effective Refractory Period ERP

  Right Ventricular Effective Refractory Period ERP (msec)

  Pre procedure/procedure

• Change in retrograde block cycle length

  Retrograde Block Cycle Length (msec)

  Pre procedure/procedure

• Change in Accessory Pathway Anterograde Effective Refractory Period ERP

  Accessory Pathway Anterograde Effective Refractory Period (msec)

  Pre procedure/procedure

• Change in Accessory Pathway Retrograde Effective Refractory Period ERP

  Accessory Pathway Anterograde Effective Refractory Period (msec)

  Pre procedure/procedure

• Supraventricular Tachycardia induction

  Supraventricular Tachycardia induction

  Pre procedure/procedure

• Supraventricular Tachycardia Termination

  Supraventricular Tachycardia Termination

  Pre procedure/procedure

Study Arms (1)

Auricular Vagal Nerve Stimulation

EXPERIMENTAL

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.

Device: Auricular Vagal Nerve Stimulation

Interventions

Auricular Vagal Nerve Stimulation DEVICE

The Parasym device will be placed on the patient's left tragus to provide transcutaneous electrical stimulation to the auricular branch of the vagus nerve.

Auricular Vagal Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• University of Oklahoma: collaborator

Study Sites (1)

Kristie Coleman

New York, New York, 10075, United States

Location

Related Publications (3)

• Stavrakis S, Stoner JA, Humphrey MB, Morris L, Filiberti A, Reynolds JC, Elkholey K, Javed I, Twidale N, Riha P, Varahan S, Scherlag BJ, Jackman WM, Dasari TW, Po SS. TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial. JACC Clin Electrophysiol. 2020 Mar;6(3):282-291. doi: 10.1016/j.jacep.2019.11.008. Epub 2020 Jan 29.

  PMID: 32192678 BACKGROUND

• Stavrakis S, Humphrey MB, Scherlag BJ, Hu Y, Jackman WM, Nakagawa H, Lockwood D, Lazzara R, Po SS. Low-level transcutaneous electrical vagus nerve stimulation suppresses atrial fibrillation. J Am Coll Cardiol. 2015 Mar 10;65(9):867-75. doi: 10.1016/j.jacc.2014.12.026.

  PMID: 25744003 BACKGROUND

• Stavrakis S, Elkholey K, Morris L, Niewiadomska M, Asad ZUA, Humphrey MB. Neuromodulation of Inflammation to Treat Heart Failure With Preserved Ejection Fraction: A Pilot Randomized Clinical Trial. J Am Heart Assoc. 2022 Feb;11(3):e023582. doi: 10.1161/JAHA.121.023582. Epub 2022 Jan 13.

  PMID: 35023349 BACKGROUND

Study Officials

• Stavros E Mountantonakis, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 27, 2022
• Study Start: August 22, 2022
• Primary Completion: April 6, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)