Sustained Auricular Nerve Stimulation for PVC Suppression
Completed · Not applicable · Has a placebo group
Conditions studied: Premature Ventricular Complexes, PVC - Premature Ventricular Contraction, Auricular Vagus Nerve Stimulation
In brief
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.
Key facts
- Study ID
- NCT07093034
- Run by
- University of California, San Diego
- People needed
- 16
- Starts
- 2025-07-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- 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.
Where it is running
- UC San Diego Health System — La Jolla, California, United States
Full record on ClinicalTrials.gov
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