An observational study in ECG, Electrocardiography and Monitoring, Physiologic, sponsored by Perin Health Devices. Completed at 1 site in United States. Open to participants aged 22 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Perin Health Devices · Observational
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:
The study has three parts that test different aspects of the device. Participants will:
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.
Perin Health Devices is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited from multiple clinical sites including hospital settings, clinical research facilities, and home healthcare providers. The population includes both healthy adult volunteers and patients with chronic cardiovascular or pulmonary conditions such as COPD, congestive heart failure, hypertension, coronary artery disease, chronic kidney disease, and diabetes. Recruitment targets a demographically diverse sample representative of the intended use population for remote cardiac monitoring, with specific attention to age, sex, BMI, and racial/ethnic diversity to ensure robust validation across patient subgroups commonly encountered in clinical practice.
Exclusion Criteria:
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.
ECG Timing Interval Equivalence Between Perin Health Patch and Reference Holter Monitor
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).
Time frame: During single 15-minute recording session and up to 15 days of continuous monitoring
Heart Rate Measurement Accuracy
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.
Time frame: During single 15-minute recording session and up to 15 days of continuous monitoring
ECG Signal Quality Equivalence
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.
Time frame: During single 15-minute recording session and up to 15 days of continuous monitoring
Device Adhesion Success Rate During Extended Wear
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.
Time frame: Over 15-day continuous monitoring period
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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