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Clinical Application of a New Handheld ECG Device

NCT07668089 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 594

Last updated 2026-06-25

No results posted yet for this study

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.

Conditions

  • Cardiac Abnormalities, Variable

Interventions

DEVICE

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.

Sponsors & Collaborators

  • HeartEye

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-22
Primary Completion
2026-07-22
Completion
2026-10-22
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07668089 on ClinicalTrials.gov