Sustained Auricular Nerve Stimulation for PVC Suppression
NCT07093034 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2025-10-16
Summary
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.
Conditions
- Premature Ventricular Complexes
- PVC - Premature Ventricular Contraction
- Auricular Vagus Nerve Stimulation
Interventions
- DEVICE
-
Extended nocturnal use of auricular vagus nerve stimulator device
Patients will wear the ParasymTM device with an ear clip on the tragus that provides stimulation at sub-detection threshold.
Sponsors & Collaborators
-
Parasym Ltd.
collaborator INDUSTRY -
Zywie Healthcare
collaborator UNKNOWN -
University of California, San Diego
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2026-03-01
- Completion
- 2026-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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