Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy

CompletedOBSERVATIONAL
Enrollment

255

Participants

Timeline

Start Date

May 21, 2025

Primary Completion Date

July 15, 2025

Study Completion Date

July 15, 2025

Conditions
ECGElectrocardiographyMonitoring, Physiologic
Interventions
DEVICE

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."

Trial Locations (1)

91364

Perin Health Devices, Woodland Hills

Sponsors
All Listed Sponsors
lead

Perin Health Devices

INDUSTRY

NCT07147920 - Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy | Biotech Hunter | Biotech Hunter