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

NCT07147920 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 255

Last updated 2025-08-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Perin Health Devices

    lead INDUSTRY

Eligibility

Min Age
22 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-21
Primary Completion
2025-07-15
Completion
2025-07-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07147920 on ClinicalTrials.gov