Clinical trial NCT05350150: Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study
Official title: Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study (VNS-EPS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromodulation
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2022-04-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Sinus Cycle Length
timeFrame: Pre procedure/procedure
measure: Change in A-H Interval
timeFrame: Pre procedure/procedure
measure: Change in H-V Interval
timeFrame: Pre procedure/procedure
measure: Change in QRS Duration
timeFrame: Pre procedure/procedure
measure: Change in QT Duration
timeFrame: Pre procedure/procedure
measure: Change in Sinus Node Recovery Time
timeFrame: Pre procedure/procedure
measure: Change in AV Node Wenckebach Cycle Length
timeFrame: Pre procedure/procedure
measure: Change in AV Node Effective Refractory Period
timeFrame: Pre procedure/procedure
measure: Change in Atrial Effective Refractory Period
timeFrame: Pre procedure/procedure
measure: Change in Right Ventricular Effective Refractory Period ERP
timeFrame: Pre procedure/procedure
measure: Change in retrograde block cycle length
timeFrame: Pre procedure/procedure
measure: Change in Accessory Pathway Anterograde Effective Refractory Period ERP
timeFrame: Pre procedure/procedure
measure: Change in Accessory Pathway Retrograde Effective Refractory Period ERP
timeFrame: Pre procedure/procedure
measure: Supraventricular Tachycardia induction
timeFrame: Pre procedure/procedure
measure: Supraventricular Tachycardia Termination
timeFrame: Pre procedure/procedure
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Kristie Coleman
state: New York
Study officials:
affiliation: Northwell Health
name: Stavros E Mountantonakis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.