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Clinical Validation of the Perin Health Patch Electrocardiogram Monitoring Device: A Multi-Component Study Evaluating Signal Quality, Placement Tolerance, and Long-Term Performance
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.
Age
22 - 90 years
Sex
ALL
Healthy Volunteers
Yes
Perin Health Devices
Woodland Hills, California, United States
Start Date
May 21, 2025
Primary Completion Date
July 15, 2025
Completion Date
July 15, 2025
Last Updated
August 29, 2025
255
ACTUAL participants
Chest-Worn ECG Monitoring Device
DEVICE
Lead Sponsor
Perin Health Devices
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04908033