Sustained Auricular Nerve Stimulation for PVC Suppression

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.

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.