Clinical Application of a New Handheld ECG Device

Starting soon

Conditions studied: Cardiac Abnormalities, Variable

In brief

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 facts

Study ID: NCT07668089
Run by: HeartEye
People needed: 594
Starts: 2026-06-22
Expected to finish: 2026-10-22
Last updated by the study team: 2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

To be eligible for enrolment in this study after adequately being informed, a participant must meet all the following criteria:
Adult (>18years old) patients admitted to the Meander Medical Centre Amersfoort (NL) or the Catharina Hospital Eindhoven (NL) visiting the outpatient clinic with a known cardiac condition or complaints suspected of cardiac disease.

You may not qualify if…

A potential participant who meets any of the following criteria will be excluded from participation in this study:
Not intact skin condition in the sternal area (e.g. recent thoracic surgery, skin eruptions, caustic trauma, etc.)
Unable to understand the procedure (e.g. comatose, incapacitated, or critically ill patients).

Full record on ClinicalTrials.gov

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