Skip to main content
OpenTrials
Completed

NCT Number: NCT07147920

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ECG Electrocardiography Monitoring, Physiologic

Age range

22 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Perin Health Devices

Woodland Hills, California, 91364, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 22 to 90 years of age
  • Healthy or chronic cardiopulmonary conditions or recent procedures
  • Able to comply with study procedure

Exclusion criteria

  • Pediatric or adolescent patients (age ≤21 years)
  • Pacemaker
  • A history of skin reactions to medical adhesives
  • Any psychosocial condition or circumstance that, in the opinion of the investigator, would interfere with the conduct of the study or the patient's care and/or safety
  • Pregnant
  • Current participation in any other clinical study
  • Refusal to participate

Treatment and study plan

Chest-Worn ECG Monitoring Device

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.

Primary outcomes

  1. ECG Timing Interval Equivalence Between Perin Health Patch and Reference Holter Monitor

    Time frame: During single 15-minute recording session and up to 15 days of continuous monitoring

    Equivalence of ECG measurements between the investigational chest patch and FDA-cleared Holter monitor using Two One-Sided Tests (TOST) statistical methodology. ECG recordings are taken simultaneously from both devices while participants sit quietly for comparison. Equivalence is demonstrated when confidence intervals for mean differences fall within pre-specified clinical margins for key ECG timing intervals including QT interval, QRS duration, and R-R interval. Signal morphology similarity is assessed using Pearson correlation coefficient (where 1.0 indicates perfect similarity) and normalized root mean square error (where 0% indicates identical signals).

Secondary outcomes

  1. Heart Rate Measurement Accuracy

    Time frame: During single 15-minute recording session and up to 15 days of continuous monitoring

    Accuracy of heart rate measurements from the investigational device compared to the reference Holter monitor. Heart rate is calculated from R-R intervals during simultaneous ECG recordings. Accuracy is assessed using mean absolute error between devices, where lower values indicate better agreement.

  2. ECG Signal Quality Equivalence

    Time frame: During single 15-minute recording session and up to 15 days of continuous monitoring

    Comparison of signal quality between the investigational device and reference monitor using signal-to-noise ratio analysis. Signal quality is measured in decibels (dB), where higher values indicate cleaner signals with less noise interference. Equivalence is assessed using statistical comparison methods to determine if signal quality differences fall within clinically acceptable ranges.

  3. Device Adhesion Success Rate During Extended Wear

    Time frame: Over 15-day continuous monitoring period

    Percentage of participants who successfully complete the full monitoring period without device adhesion failure. Adhesion failure is defined as device detachment that prevents reliable ECG signal acquisition. Success is measured by the proportion of participants maintaining adequate device adherence throughout the intended wear duration.

Sponsors and collaborators

Lead sponsor

Perin Health Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.