TREAT-PVCLow-Level Tragus Stimulation for Frequent Premature Ventricular Contractions

This study focuses on a common type of irregular heartbeat known as Premature Ventricular Contraction (PVC). PVCs can potentially harm patients by increasing the risk of heart disease, triggering other serious heart rhythms, and worsening existing heart conditions. Currently, treatment for PVCs primarily involves medication, but effectiveness varies greatly among individuals. The study aims to explore a new, non-invasive method called low-level tragus stimulation (LLTS) to manage PVCs. This method involves stimulating the vagus nerve through the tragus of the ear, which has shown promise in reducing symptoms related to heart conditions and other disorders. The study is designed as a randomized, single-blind trial involving 100 patients. Participants are divided into two groups: one receiving active LLTS and the other receiving a sham treatment. The active LLTS is administered using a device called the Parasym device, which stimulates the vagus nerve through an ear clip attached to the tragus. The sham treatment involves attaching the clips to the earlobe, which does not affect the vagus nerve. Patients' heart activity is monitored at baseline, 3 months, and 6 months using a non-invasive, adhesive ECG patch. The study measures the burden of PVCs, or the percentage of premature ventricular beats in total heartbeats. Additionally, it evaluates heart rate variability, quality of life, skin sympathetic nerve activity, and serum cytokine levels at baseline and follow-up.