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NCT Number: NCT05350150

Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Neuromodulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kristie Coleman

New York, 10075, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Sinus Cycle Length

    Time frame: Pre procedure/procedure

    Sinus cycle length (msec)

  2. Change in A-H Interval

    Time frame: Pre procedure/procedure

    A-H Interval (msec)

  3. Change in H-V Interval

    Time frame: Pre procedure/procedure

    H-V interval (msec)

  4. Change in QRS Duration

    Time frame: Pre procedure/procedure

    QRS Duration (msec)

  5. Change in QT Duration

    Time frame: Pre procedure/procedure

    QT Duration (msec)

  6. Change in Sinus Node Recovery Time

    Time frame: Pre procedure/procedure

    Sinus Node Recovery Time (msec)

  7. Change in AV Node Wenckebach Cycle Length

    Time frame: Pre procedure/procedure

    AV Node Wenckebach Cycle Length (msec)

  8. Change in AV Node Effective Refractory Period

    Time frame: Pre procedure/procedure

    AV Node Effective Refractory Period (ERP) (msec)

  9. Change in Atrial Effective Refractory Period

    Time frame: Pre procedure/procedure

    Atrial Effective Refractory Period ERP (msec)

  10. Change in Right Ventricular Effective Refractory Period ERP

    Time frame: Pre procedure/procedure

    Right Ventricular Effective Refractory Period ERP (msec)

  11. Change in retrograde block cycle length

    Time frame: Pre procedure/procedure

    Retrograde Block Cycle Length (msec)

  12. Change in Accessory Pathway Anterograde Effective Refractory Period ERP

    Time frame: Pre procedure/procedure

    Accessory Pathway Anterograde Effective Refractory Period (msec)

  13. Change in Accessory Pathway Retrograde Effective Refractory Period ERP

    Time frame: Pre procedure/procedure

    Accessory Pathway Anterograde Effective Refractory Period (msec)

  14. Supraventricular Tachycardia induction

    Time frame: Pre procedure/procedure

    Supraventricular Tachycardia induction

  15. Supraventricular Tachycardia Termination

    Time frame: Pre procedure/procedure

    Supraventricular Tachycardia Termination

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • University of Oklahoma

Registry information

Official study title

Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study (VNS-EPS)

Acronym: VNS-EPS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2022
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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