An interventional study of Extended nocturnal use of auricular vagus nerve stimulator device in Premature Ventricular Complexes, PVC - Premature Ventricular Contraction and Auricular Vagus Nerve Stimulation, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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.
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.
102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.
This study's enrollment of 16 is below the median of 84 across 58 interventional studies indexed under Ventricular Premature Complexes.
Browse Ventricular Premature Complexes studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
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
Willingness to comply with all study procedures
Availability for the duration of the study (10 weeks)
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 \< 20%
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Extended nocturnal use of auricular vagus nerve stimulator device
Device: 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.
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
Time frame: 10 weeks (duration of entire study)
Tolerability
Participants will rate tolerability of wearing the device at night at multiple pre-specified time points throughout the study
Time frame: 10 weeks
Quality of Life
Participants will rate quality of life at multiple pre-specified time points throughout the study
Time frame: 10 weeks
Feasibility
Participants will rate ease of wearing the device at night at multiple pre-specified time points throughout the study
Time frame: 10 weeks
PVC burden
PVC burden will be tracked by event monitoring at pre-specified time points throughout the study
Time frame: 10 weeks
PVC Burden stratified by timing
PVC burden during night time 12 hours and day time 12 hours will be compared to see if there is a significant difference
Time frame: 10 weeks
Heart rate variability (HRV)
HRV will be tracked throughout the study via event monitors at prespecified time points
Time frame: 10 weeks
Plan to share: Undecided — IPD will be shared if requested by the receiving journal or reviewer. We will de-identify the data prior to providing this information.
Ran from Jul 2025 to primary completion in Jul 2026, 12 months.
Of 32 interventional studies with no phase under Ventricular Premature Complexes, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 52. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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