A prospective sham-controlled randomized clinical trial to assess the effect of low-level tragus stimulation (LLTS) in patients with frequent premature ventricular complexes (PVCs)
This is a two-center, prospective, cross-over, sham-controlled, double-blinded, randomized clinical trial. All the patients will receive a cardiac event monitor at baseline for 28 days, the patient will switch the ePatch after 14 days . Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS. Each treatment period (sham-stimulation and LLTS) will last 10 days. The Parasym device will be used, and the patients will receive LLTS or sham-stimulation for 1 hour daily. The wash-out period between the two treatments will last 8 days. Patients will be continually monitored via event monitor for 28 days in duration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
The study will utilize the Parasym device (Parasym Health, London, United Kingdom) paired with compatible electrodes to administer the transcutaneous LLTS.
Sham device
Northwell Health
New York, New York, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
PVC Burden
Daily PVC Count by event monitor
Time frame: 28 days
Quality of life survey
SF 36 QOL Score
Time frame: 28 days
Heart Rate Variability
Daily HRV
Time frame: 28 days
PVC Morphology
Fluctuation in PVC Morphology by event monitor
Time frame: 28 days
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