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Clinical Application of a New Handheld ECG Device
Sponsor: HeartEye
Summary
To investigate possible heart disease, an electrocardiogram (ECG) is needed. For this, a person usually must go to the hospital, sometimes urgently. There, an ECG is performed using a device with 10 wires attached to the skin with adhesive pads or suction cups. Taken together, a time-consuming procedure. With a simple and pocket-size ECG device, it is being investigated whether this procedure can be made faster and easier, thereby improving the availability and accessibility of a heart tracing. With a simple and pocket-size ECG device, it is being investigated whether this procedure can be made faster and easier, thereby improving the availability and accessibility of a heart tracing. By holding this new device against the chest, a heart recording is made and stored via a smartphone so that it can be remotely reviewed by a doctor. The goal of this study is to establish that the new method of ECG registration is at least as good as the conventional way. The number of successfully completed (suitable for interpretation) ECGs will be compared to the total number of ECG registrations; also, the number of adverse events will be scored as well as user satisfaction. There are no risks associated with participating in this study. The burden is minimal: an extra ECG within 1 minute without using any adhesives or wires.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
594
Start Date
2026-06-22
Completion Date
2026-10-22
Last Updated
2026-06-25
Healthy Volunteers
No
Conditions
Interventions
ECG registration with a handheld ECG device.
Patients admitted to the hospital that are subjected to routine ECG registration can be enrolled in the study by adding a HeartEye ECG nearly simultaneously, meaning within 5 minutes before or after the routine ECG registration. Another 60 seconds per ECG added to the procedure due to enrolment in this study, causing a minimal burden for the patient.