ECGNCT07147920
Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy
An observational study of ECG and Electrocardiography, run by Perin Health Devices at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- ECG, Electrocardiography, Monitoring, Physiologic
- What is being tested?
- Chest-Worn ECG Monitoring Device
- Type of treatment
- Medical device
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2025to 15 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults 22 to 90 years of age
- Healthy or chronic cardiopulmonary conditions or recent procedures
- Able to comply with study procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Perin Health Devices
Woodland Hills, California, 91364
About this study
Official title: 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?
Read more
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
- Being tested
- Chest-Worn ECG Monitoring Device
- Keywords
- ECG validation study, electrocardiogram accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest-Worn ECG Monitoring DeviceDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During single 15-minute recording session and up to 15 days of continuous monitoring
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Over 15-day continuous monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start21 May 2025
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perin Health Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147920
- Sponsor's protocol ID
- TP-25-001
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Perin Health Patch Electrocardiogram Monitoring Device: A Multi-Component Study Evaluating Signal Quality, Placement Tolerance, and Long-Term Performance
- ClinicalTrials.gov ID
- NCT07147920
- Acronym / sponsor ID
- TP-25-001
- Conditions
- ECG, Electrocardiography, Monitoring, Physiologic
- Keywords
- ECG validation study, electrocardiogram accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Perin Health DevicesIndustry (pharma, biotech, devices)
- Study start
- 21 May 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Adults 22 to 90 years of age
- Healthy or chronic cardiopulmonary conditions or recent procedures
- Able to comply with study procedure
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest-Worn ECG Monitoring DeviceThe 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. | Device | – |
Primary outcome
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).
3 secondary outcomes
Heart Rate Measurement Accuracy
Time frame: During single 15-minute recording session and up to 15 days of continuous monitoring
ECG Signal Quality Equivalence
Time frame: During single 15-minute recording session and up to 15 days of continuous monitoring
Device Adhesion Success Rate During Extended Wear
Time frame: Over 15-day continuous monitoring period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ECG and Electrocardiography, run by Perin Health Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.