Neuromodulation Clinical Trial
— VNS-EPSOfficial title:
Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study (VNS-EPS)
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Kristie Coleman | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health | University of Oklahoma |
United States,
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
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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