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NCT07147920 · ClinicalTrials.gov registry record
Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy
A clinical trial, sponsored by Perin Health Devices.
- Completed
- Registry status
- 255
- Enrollment target
NCT07147920: Completed study, sponsored by Perin Health Devices.
NCT07147920 is a clinical trial that has completed, run by Perin Health Devices. The registered enrollment target is 255 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07147920 has completed, sponsored by Perin Health Devices.
- COMPLETED
- Registry status
- 255 participants
- Enrollment target
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.
Primary Outcome
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
Interventions
- DEVICE Chest-Worn ECG Monitoring Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2025-05-21 |
| Est. Completion | 2025-07-15 |
What the finished NCT07147920 record still lists
NCT07147920 is an observational study that tracks outcomes without assigning an intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Chest-Worn ECG Monitoring Device is the first listed.
NCT07147920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07147920 about?
NCT07147920 is a clinical study titled "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...
What is the current status of trial NCT07147920?
This trial is currently completed. The enrollment target is 255 participants. The study started on 2025-05-21. Estimated completion is 2025-07-15.
What interventions are being tested in trial NCT07147920?
The interventions under investigation include: Chest-Worn ECG Monitoring Device (DEVICE).
Who is sponsoring clinical trial NCT07147920?
This trial is sponsored by Perin Health Devices, which has 5 total clinical trials registered on ClinicalTrials.gov.
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