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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05350150
Other study ID # 21-1109
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 22, 2022
Est. completion date November 30, 2024

Study information

Verified date January 2024
Source Northwell Health
Contact Kristie Coleman, RN
Phone 2124346500
Email kcoleman1@northwell.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Auricular Vagal Nerve Stimulation
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.

Locations

Country Name City State
United States Kristie Coleman New York New York

Sponsors (2)

Lead Sponsor Collaborator
Northwell Health University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

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