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Premature Ventricular ComplexesSANS-PVCNCT07093034

Sustained Auricular Nerve Stimulation for PVC Suppression

A study testing Extended nocturnal use of auricular vagus nerve stimulator device in people with Premature Ventricular Complexes and PVC - Premature Ventricular Contraction, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Non-invasive vagus nerve stimulation has been clinically tested for the treatment cardiac arrhythmias. However, prior studies have shown mixed results-possibly in part due to inadequate stimulation duration. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Extended nocturnal use of auricular vagus nerve stimulator device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
1 Jul 2025to 1 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals must meet all of the following inclusion criteria to be eligible to participate in this study:
  • Age ≥ 18 years
  • 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)
Show all 15Show fewer
  • Individuals meeting any of the following exclusion criteria at baseline will be excluded from study participation:
  • Unwilling or unable to provide informed consent for oneself
  • 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:
  • This study will not exclude specific populations based on age, sex, race, or ethnicity. The inclusion/exclusion criteria are based on clinical factors relevant to the study intervention and the safety of participants. Limited English proficiency will not be an exclusion criterion, and appropriate translation services will be provided to ensure informed consent and understanding of study procedures.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UC San Diego Health System

    La Jolla, California, 92037

Other trials in United States

About this study

Non-invasive vagus nerve stimulation has been clinically tested for the treatment cardiac arrhythmias. However, prior studies have shown mixed results-possibly in part due to inadequate stimulation duration. Therefore, we have designed an investigator-initiated early feasibility study to evaluate safety, tolerability, and compliance with prolonged, nocturnal auricular nerve stimulation using the Parasym device.

Read the detailed description

The study will utilize the Parasym transcutaneous auricular vagal nerve stimulation device. This small, battery-powered device delivers electrical stimulation through an ear clip attached to the tragus. Participants will self-administer the stimulation once daily, at bedtime, for 6 continuous hours. The device has two settings to facilitate our RCT: active treatment and sham control. After one month in the first treatment arm, participants will be crossed over to the other arm of the study. Participants and outcome assessors will be blinded to the allocation. The primary outcomes will be assessed via standardized questionnaires administered by blinded outcome assessors. The secondary outcome of PVC burden will be assessed by non-invasive event monitors.

Being tested
Extended nocturnal use of auricular vagus nerve stimulator device
Keywords
auricular vagus nerve stimulation, parasym, premature ventricular contractions (PVCs), Non-invasive neuromodulation, Cardiac arrhythmia, autonomic nervous system modulation, Trancutaneous electrical stimulation, Randomized controlled trial, heart rate variability, feasibility study
Medical subject headings
Ventricular Premature Complexes, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended nocturnal use of auricular vagus nerve stimulator deviceDevice

    Patients will wear the ParasymTM device with an ear clip on the tragus that provides stimulation at sub-detection threshold.

Study groups in NCT07093034
Study groupRoleWhat they receive
Arm 1: Active stimulation followed by crossover to Sham stimulationExperimentalNot described
Receives: Device: Extended nocturnal use of auricular vagus nerve stimulator device
Arm 2: Sham stimulation followed by crossover to Active stimulationExperimentalNot described
Receives: Device: Extended nocturnal use of auricular vagus nerve stimulator device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    The occurrence of adverse events (AEs) throughout the study - including major, minor, severe adverse events and whether they lead to discontinuation of the device

    Measured: 10 weeks (duration of entire study)

  2. Tolerability

    Participants will rate tolerability of wearing the device at night at multiple pre-specified time points throughout the study

    Measured: 10 weeks

  3. Quality of Life

    Participants will rate quality of life at multiple pre-specified time points throughout the study

    Measured: 10 weeks

  4. Feasibility

    Participants will rate ease of wearing the device at night at multiple pre-specified time points throughout the study

    Measured: 10 weeks

Secondary outcomes (1)
  1. PVC burden

    PVC burden will be tracked by event monitoring at pre-specified time points throughout the study

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start1 Jul 2025
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07093034
Sponsor's protocol ID
812185
Acronym
SANS-PVC
Status last verified
Jul 2026
First submitted
14 Jul 2025
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: IPD will be shared if requested by the receiving journal or reviewer. We will de-identify the data prior to providing this information.

Publications

  • 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.

    PubMed 36543841
  • 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.

    PubMed 39402309
  • 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.

    PubMed 37727325
  • 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.

    PubMed 25573069
  • 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.

    PubMed 32192678
  • 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.

    PubMed 37999672
  • 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.

    PubMed 38173801
  • 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.

    PubMed 25187002
  • 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.

    PubMed 27058909
  • 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.

    PubMed 25176942
  • 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.

    PubMed 21030409
  • 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.

    PubMed 14662714
  • 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.

    PubMed 4398792

Questions about this trial

What is this clinical trial studying?

A study testing Extended nocturnal use of auricular vagus nerve stimulator device in people with Premature Ventricular Complexes and PVC - Premature Ventricular Contraction, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 10 weeks (duration of entire study)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07093034, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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