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| Name | Class |
|---|---|
| University of Oklahoma | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stavros E Mountantonakis, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kristie Coleman | New York | New York | 10075 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32192678 | Background | 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. | |
| 25744003 |
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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 |
| 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. |
| 35023349 | 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. |