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Clinical Application of a New Handheld ECG Device

Clinical Application of a New Handheld ECG Device (CANHED) - Clinical Application of a New Handheld ECG Device

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58578
Enrollment
594
Registered
2026-01-14
Start date
2026-08-20
Completion date
Unknown
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease Heart disease

Interventions

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 medical doctor.

Sponsors

HeartEye bv
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
Non-inferiority to the traditional ECG registration should be established. 

Secondary

MeasureTime frame
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.

Countries

Netherlands

Contacts

Public ContactM.C. Zee

HeartEye bv

rien@hearteye.nl+31 6 55756354

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Sep 19, 2026