Auricular Vagus Nerve Stimulation for Premature Ventricular Contractions

(SANS-PVC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Low ejection fraction, NYHA IV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device that stimulates a nerve in the ear to reduce irregular heartbeats, known as premature ventricular contractions (PVCs). Researchers aim to determine if using this device at night is safe and easy to tolerate. Participants will use either the active device or a sham (inactive) device and then switch to the other. Individuals with frequent PVCs that impact daily life and who can adhere to study procedures are well-suited for this trial. As an unphased trial, this study allows participants to contribute to innovative research that could enhance heart health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this device is safe for treating premature ventricular contractions?

Research has shown that stimulating the vagus nerve in the ear is usually well-tolerated. In one study, 16% of participants reported minor side effects, but no major safety concerns arose. This indicates that while some might experience mild discomfort, serious problems are rare. Researchers are studying this treatment for its potential to help with heart rhythm issues, such as premature ventricular contractions (PVCs). Although earlier tests produced mixed results, ongoing research aims to refine the method for better outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for premature ventricular contractions (PVCs) involve medications like beta-blockers or calcium channel blockers that work by altering the heart's electrical impulses. However, this new approach is unique because it uses auricular vagus nerve stimulation, which is a non-invasive method that targets the nerve pathways affecting heart rhythm. Researchers are excited because this treatment could offer a safer alternative with fewer side effects compared to drugs. Plus, the use of a wearable device for overnight use makes it convenient and potentially more consistent in managing PVCs.

What evidence suggests that this device is effective for premature ventricular contractions?

Research has shown that stimulating the auricular vagus nerve can reduce the occurrence of premature ventricular contractions (PVCs), which are extra heartbeats originating in the heart's lower chambers. One study found that this stimulation lowered PVCs by about 13.4% compared to a sham treatment. Another study also demonstrated a significant decrease in PVCs with this treatment compared to a sham. However, past research has produced mixed results, possibly due to the short duration of stimulation. This trial will compare extended nocturnal use of the auricular vagus nerve stimulator device in two groups: one starting with active stimulation followed by crossover to sham stimulation, and the other starting with sham stimulation followed by crossover to active stimulation, to determine if longer use is more effective. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with irregular heartbeats known as Premature Ventricular Contractions (PVCs). Participants should be willing to use a non-invasive ear device at night that stimulates the vagus nerve, which may help control their heart rhythm.

Inclusion Criteria

Provide written informed consent

PVC burden ≥ 10% documented on an event monitor or implanted cardiac device

I am 18 years old or older.

Exclusion Criteria

Active pregnancy or breastfeeding

Intention to become pregnant

I am unable or unwilling to give my consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-administer auricular nerve stimulation using the Parasym device for 6 continuous hours at bedtime, with crossover between active and sham stimulation after one month

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Extended nocturnal use of auricular vagus nerve stimulator device

Trial Overview The study tests if using an auricular vagus nerve stimulator device during sleep can safely and effectively reduce PVCs. It's an early feasibility study focusing on how well participants tolerate extended nocturnal use of the Parasym device.

How Is the Trial Designed?

Group I: Arm 2: Sham stimulation followed by crossover to Active stimulation Experimental Treatment 1 Intervention

Group II: Arm 1: Active stimulation followed by crossover to Sham stimulation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Parasym Ltd.

Industry Sponsor

Trials

1

Recruited

80+

Zywie Healthcare

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11285463/

Efficacy and safety of transcutaneous auricular vagus nerve ... Secondary outcomes include the proportion of patients with a ≥ 75% reduction in PVCs, as well as the changes in premature ventricular beats, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X25002646

Transcutaneous Electrical Vagus Nerve Stimulation to ... Outcomes. We found that LLTS resulted in a significant reduction of the PVC burden compared with sham stimulation (10.5% [IQR: 14.4%] vs 8.59 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07093034

Sustained Auricular Nerve Stimulation for PVC Suppression Non-invasive vagus nerve stimulation has been clinically tested for the treatment cardiac arrhythmias. However, prior studies have shown mixed ...

4. jacc.org jacc.org/doi/abs/10.1016/j.jacep.2025.04.011

A Crossover, Randomized Clinical Trial (NoVa-PVC) The median baseline PVC burden was 12.00% (IQR: 11.4%). LLTS significantly reduced the median PVC burden by 13.4% compared with sham stimulation (10.5% [IQR: ...

5. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT07093034

Sustained Auricular Nerve Stimulation for PVC Suppression Summary. Non-invasive vagus nerve stimulation has been clinically tested for the treatment cardiac arrhythmias. However, prior studies have shown mixed results- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07026695

Transcutaneous Vagus Nerve Stimulation for Ventricular ... They can cause debilitating symptoms when they occur intermittently (these are called premature ventricular ectopics or PVCs) and can be life-threatening when ...