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

Perin Health Devices

Status: Completed

Conditions: ECG; Electrocardiography; Monitoring, Physiologic

Treatments: Device: Chest-Worn ECG Monitoring Device

Study type: Observational

Funder types: Industry

Identifiers

NCT07147920

TP-25-001

Details and patient eligibility

About

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.

Enrollment: 255 patients

Sex: All

Ages: 22 to 90 years old

Volunteers: Accepts Healthy Volunteers

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