Sustained Auricular Nerve Stimulation for PVC Suppression
NCT ID: NCT07093034
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
16 participants
INTERVENTIONAL
2025-07-01
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Arm 1: Active stimulation followed by crossover to Sham stimulation
Extended nocturnal use of auricular vagus nerve stimulator device
Patients will wear the ParasymTM device with an ear clip on the tragus that provides stimulation at sub-detection threshold.
Arm 2: Sham stimulation followed by crossover to Active stimulation
Extended nocturnal use of auricular vagus nerve stimulator device
Patients will wear the ParasymTM device with an ear clip on the tragus that provides stimulation at sub-detection threshold.
Interventions
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Extended nocturnal use of auricular vagus nerve stimulator device
Patients will wear the ParasymTM device with an ear clip on the tragus that provides stimulation at sub-detection threshold.
Eligibility Criteria
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Inclusion Criteria
PVC burden ≥ 5% documented on an event monitor or implanted cardiac device
Provide written informed consent
Willingness to comply with all study procedures
Availability for the duration of the study (10 weeks)
Exclusion Criteria
Last available left ventricular ejection fraction \< 20%
NYHA Class IV symptoms
Acute coronary syndrome within two weeks of randomization
Active pregnancy or breastfeeding
Intention to become pregnant
Statement Regarding Equitable Selection:
18 Years
ALL
No
Sponsors
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Parasym Ltd.
INDUSTRY
Zywie Healthcare
UNKNOWN
University of California, San Diego
OTHER
Responsible Party
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Ulrika Birgersdotter-Green
Professor of Medicine
Locations
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UC San Diego Health System
La Jolla, California, United States
Countries
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References
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Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.
Gentile F, Giannoni A, Navari A, Degl'Innocenti E, Emdin M, Passino C. Acute right-sided transcutaneous vagus nerve stimulation improves cardio-vagal baroreflex gain in patients with chronic heart failure. Clin Auton Res. 2025 Feb;35(1):75-85. doi: 10.1007/s10286-024-01074-9. Epub 2024 Oct 14.
Hua K, Cummings M, Bernatik M, Brinkhaus B, Usichenko T, Dietzel J. Cardiovascular effects of auricular stimulation -a systematic review and meta-analysis of randomized controlled clinical trials. Front Neurosci. 2023 Sep 1;17:1227858. doi: 10.3389/fnins.2023.1227858. eCollection 2023.
Frangos E, Ellrich J, Komisaruk BR. Non-invasive Access to the Vagus Nerve Central Projections via Electrical Stimulation of the External Ear: fMRI Evidence in Humans. Brain Stimul. 2015 May-Jun;8(3):624-36. doi: 10.1016/j.brs.2014.11.018. Epub 2014 Dec 6.
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.
Stavrakis S, Chakraborty P, Farhat K, Whyte S, Morris L, Abideen Asad ZU, Karfonta B, Anjum J, Matlock HG, Cai X, Yu X. Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. JACC Clin Electrophysiol. 2024 Feb;10(2):346-355. doi: 10.1016/j.jacep.2023.10.015. Epub 2023 Nov 22.
Chakraborty P, Farhat K, Morris L, Whyte S, Yu X, Stavrakis S. Non-invasive Vagus Nerve Simulation in Postural Orthostatic Tachycardia Syndrome. Arrhythm Electrophysiol Rev. 2023 Dec 13;12:e31. doi: 10.15420/aer.2023.20. eCollection 2023.
Premchand RK, Sharma K, Mittal S, Monteiro R, Dixit S, Libbus I, DiCarlo LA, Ardell JL, Rector TS, Amurthur B, KenKnight BH, Anand IS. Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: results of the ANTHEM-HF trial. J Card Fail. 2014 Nov;20(11):808-16. doi: 10.1016/j.cardfail.2014.08.009. Epub 2014 Sep 1.
Gold MR, Van Veldhuisen DJ, Hauptman PJ, Borggrefe M, Kubo SH, Lieberman RA, Milasinovic G, Berman BJ, Djordjevic S, Neelagaru S, Schwartz PJ, Starling RC, Mann DL. Vagus Nerve Stimulation for the Treatment of Heart Failure: The INOVATE-HF Trial. J Am Coll Cardiol. 2016 Jul 12;68(2):149-58. doi: 10.1016/j.jacc.2016.03.525. Epub 2016 Apr 4.
Zannad F, De Ferrari GM, Tuinenburg AE, Wright D, Brugada J, Butter C, Klein H, Stolen C, Meyer S, Stein KM, Ramuzat A, Schubert B, Daum D, Neuzil P, Botman C, Castel MA, D'Onofrio A, Solomon SD, Wold N, Ruble SB. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial. Eur Heart J. 2015 Feb 14;36(7):425-33. doi: 10.1093/eurheartj/ehu345. Epub 2014 Aug 31.
De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J, Raspopovic S, Klein H, Swedberg K, Schwartz PJ; CardioFit Multicenter Trial Investigators. Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure. Eur Heart J. 2011 Apr;32(7):847-55. doi: 10.1093/eurheartj/ehq391. Epub 2010 Oct 28.
Li M, Zheng C, Sato T, Kawada T, Sugimachi M, Sunagawa K. Vagal nerve stimulation markedly improves long-term survival after chronic heart failure in rats. Circulation. 2004 Jan 6;109(1):120-4. doi: 10.1161/01.CIR.0000105721.71640.DA. Epub 2003 Dec 8.
Eckberg DL, Drabinsky M, Braunwald E. Defective cardiac parasympathetic control in patients with heart disease. N Engl J Med. 1971 Oct 14;285(16):877-83. doi: 10.1056/NEJM197110142851602. No abstract available.
Other Identifiers
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812185
Identifier Type: -
Identifier Source: org_study_id
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