Sustained Auricular Nerve Stimulation for PVC Suppression

N/AEnrolling By InvitationNCT07093034

University of California, San Diego16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Premature Ventricular Complexes PVC - Premature Ventricular Contraction Auricular Vagus Nerve Stimulation

Interventions

Extended nocturnal use of auricular vagus nerve stimulator deviceDEVICE

Patients will wear the ParasymTM device with an ear clip on the tragus that provides stimulation at sub-detection threshold.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UC San Diego Health System

La Jolla, California, United States

Outcomes

Primary Outcomes

Safety

The occurrence of adverse events (AEs) throughout the study.

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

Secondary Outcomes

PVC burden

PVC burden will be tracked by event monitoring at pre-specified time points throughout the study

Time frame: 10 weeks

Data from ClinicalTrials.gov

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