Clinical Application of a New Handheld ECG Device

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.

NCT Number	NCT07668089
Lead Sponsor	HeartEye
Conditions	Cardiac Abnormalities, Variable
Enrollment	594 participants
Start Date	2026-06-22
Primary Completion	2026-07-22 (estimated)
Study Completion	2026-10-22 (estimated)
Updated on ClinicalTrials.gov	2026-06-25