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 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.

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 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.