NCT07147920

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

Clinical Validation of the Perin Health Patch Electrocardiogram Monitoring Device: A Multi-Component Study Evaluating Signal Quality, Placement Tolerance, and Long-Term Performance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 255 (actual)
• Sponsor: Perin Health Devices · Industry
• Sex: All
• Age: 22 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to test how accurately and reliably a new chest-worn device called the Perin Health Patch measures heart rhythms (ECG) in adults aged 22 and older. The main questions it aims to answer are: * How accurately does the Perin Health Patch measure heart rhythm compared to standard hospital ECG monitoring equipment? * Does the patch still work properly if it's placed slightly off from the exact recommended position on the chest? * Does the patch maintain good performance when worn continuously for 15 days? The study has three parts that test different aspects of the device. Participants will: * Wear the Perin Health Patch on their chest along with standard ECG monitoring equipment for comparison * Have ECG recordings taken while sitting quietly for 15 minutes * For the placement study: have the patch placed in several different positions to test if small placement errors affect performance * For the long-term study: wear the patch continuously for 15 days at home with regular check-ups on days 1, 7, 10, and 15 The study will include both healthy adults and people with heart or lung conditions like heart failure, COPD, high blood pressure, or diabetes to test how well the device works for different types of patients. Researchers will compare the heart rhythm measurements from the chest patch to standard medical monitoring equipment to determine if the patch is accurate enough for medical use. Some participants will complete just one part of the study, while others may participate in multiple parts depending on which aspect of the device is being tested.

Conditions

• ECG
• Electrocardiography
• Monitoring, Physiologic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-21
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2025-08-29
• Last updated: 2025-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study