255
Participants
Start Date
May 21, 2025
Primary Completion Date
July 15, 2025
Study Completion Date
July 15, 2025
Chest-Worn ECG Monitoring Device
"The Perin Health Patch is a non-invasive, chest-worn wearable device designed to continuously monitor electrocardiogram (ECG) signals using dry conductive adhesive electrodes. In this validation study, the device will be evaluated for its ability to accurately measure ECG parameters including heart rate, QT interval, QRS duration, and R-R intervals compared to FDA-cleared Holter monitors.~The study intervention involves three components: (1) simultaneous ECG recording with the patch and reference Holter monitor for 15 minutes while participants remain seated, (2) placement tolerance testing where the patch is positioned at various locations (±20mm from optimal placement) to assess performance under suboptimal positioning, and (3) long-term wear evaluation where participants wear the patch continuously for 15 days with periodic assessments. The intervention is limited to device application and ECG data collection under controlled conditions, with no therapeutic treatment provided."
Perin Health Devices, Woodland Hills
Lead Sponsor
Perin Health Devices
INDUSTRY