Cardiac Abnormalities, VariableCANHEDNCT07668089
Clinical Application of a New Handheld ECG Device
An observational study of Cardiac Abnormalities, Variable, run by HeartEye.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Abnormalities, Variable
- What is being tested?
- ECG registration with a handheld ECG device.
- Type of treatment
- Medical device
- How many people
- 594 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2026to 22 Oct 2026
- How long will I take part?
- 594 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting a hospital with a known cardiac condition or complaints suspected of cardiac disease.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
Cardiovascular diseases (CVD) affect around 620Mn people, 1 in 13 of the world's population. The number of people affected is increasing due to changing lifestyles and a growing and aging population. CVDs are a leading cause of mortality and morbidity worldwide. They place a significant burden on healthcare systems, government budgets, and the lives of patients and caregivers. In 2019, CVDs accounted for 17.9Mn deaths worldwide - 32% of all deaths.
Specifically, heart attacks and strokes were responsible for 85% of these deaths, with a third occurring prematurely in individuals under 70 years4. The total annual costs of CVDs, including healthcare costs, productivity losses, and informal care, are estimated to be around €210Bn in Europe and €380Bn in the US.
Over the past decades, significant progress in CVD diagnostics has resulted in a wide range of diagnostic tools. However, the gold-standard 12-lead ECG remains indispensable for accurately detecting complex and life-threatening cardiac conditions like myocardial infarction (MI). While simpler devices provide convenience, they lack the precision needed for diagnosing such critical pathologies.
HeartEye is a Dutch pioneering medical technology company that has developed and aims to receive regulatory approvals of a handheld ECG device to provide accessible, accurate, and user-friendly electrocardiogram (ECG) diagnostics through innovative technology, and portable, medical-grade devices that empower individuals and healthcare professionals (HCPs) with timely and precise cardiac health insights.
To test the employment, feasibility, clinical performance, and safety of HeartEye's ECG device, 594 patients admitted to the hospital will be enrolled for (near) simultaneous registration of a standard ECG and a HeartEye ECG for comparison of diagnosis by an independent expert panel of cardiologists to assess the degree of agreement. A HeartEye ECG can be performed within 60 seconds by simply holding the device against the chest without the use of adhesives, thereby causing minimal burden or risks for patients, if any.
- Conditions
- Cardiac Abnormalities, Variable
- Being tested
- ECG registration with a handheld ECG device.
- Keywords
- Handheld ECG device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG registration with a handheld ECG device.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.
| Study group | Role | What they receive |
|---|---|---|
| Patients visiting a hospital that are scheduled for an ECG registration receive 1 additional ECG | Patients diagnosed with various conditions will be selected to create a diverse mixture of cardiac pathology in the following categories:
1. Normal, atypical cardiac complaints, extrasystole
2. Ischemic diseases
3. Arrhythmia, conduction delay
4. Cardiomyopathy
5. Pacemaker therapy
6. Systemic diseases (e.g., hypothyroidism, electrolyte disorder) Intervention: 1 additional ECG with a handheld ECG device. Receives: Device: ECG registration with a handheld ECG device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective: To test non-inferiority, diagnostic agreement of the 12 lead HeartEye ECG will be determined by comparing individual cardiologist diagnosis per category to the traditional ECG.
Measured: 4 months after first inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion22 Jul 2026 (estimated)
- Study completion22 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac Abnormalities, VariableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 594 participants (estimated)
- Target duration
- 594 Days
Sponsor and investigators
- Lead sponsor
- HeartEye
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668089
- Sponsor's protocol ID
- NL011365
- Acronym
- CANHED
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: ECG data. Patients characteristics. Questionnaires.
Publications
Zepeda-Echavarria A, van de Leur RR, Vessies M, de Vries NM, van Sleuwen M, Hassink RJ, Wildbergh TX, van Doorn JL, van der Zee R, Doevendans PA, Jaspers JEN, van Es R. Detection of acute coronary occlusion with a novel mobile electrocardiogram device: a pilot study. Eur Heart J Digit Health. 2024 Jan 17;5(2):183-191. doi: 10.1093/ehjdh/ztae002. eCollection 2024 Mar.
PubMed 38505481de Vries NM, Zepeda-Echavarria A, van de Leur RR, Loen V, Vos MA, Boonstra MJ, Wildbergh TX, Jaspers JEN, van der Zee R, Slump CH, Doevendans PA, van Es R. Detection of Ischemic ST-Segment Changes Using a Novel Handheld ECG Device in a Porcine Model. JACC Adv. 2023 Jul 19;2(5):100410. doi: 10.1016/j.jacadv.2023.100410. eCollection 2023 Jul.
PubMed 38939006
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of a New Handheld ECG Device
- ClinicalTrials.gov ID
- NCT07668089
- Acronym / sponsor ID
- CANHED / NL011365
- Conditions
- Cardiac Abnormalities, Variable
- Keywords
- Handheld ECG device
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- HeartEyeIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 22 Jul 2026 (estimated)
- Study completion
- 22 Oct 2026 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular diseases (CVD) affect around 620Mn people, 1 in 13 of the world's population. The number of people affected is increasing due to changing lifestyles and a growing and aging population. CVDs are a leading cause of mortality and morbidity worldwide. They place a significant burden on healthcare systems, government budgets, and the lives of patients and caregivers. In 2019, CVDs accounted for 17.9Mn deaths worldwide - 32% of all deaths.
Specifically, heart attacks and strokes were responsible for 85% of these deaths, with a third occurring prematurely in individuals under 70 years4. The total annual costs of CVDs, including healthcare costs, productivity losses, and informal care, are estimated to be around €210Bn in Europe and €380Bn in the US.
Over the past decades, significant progress in CVD diagnostics has resulted in a wide range of diagnostic tools. However, the gold-standard 12-lead ECG remains indispensable for accurately detecting complex and life-threatening cardiac conditions like myocardial infarction (MI). While simpler devices provide convenience, they lack the precision needed for diagnosing such critical pathologies.
HeartEye is a Dutch pioneering medical technology company that has developed and aims to receive regulatory approvals of a handheld ECG device to provide accessible, accurate, and user-friendly electrocardiogram (ECG) diagnostics through innovative technology, and portable, medical-grade devices that empower individuals and healthcare professionals (HCPs) with timely and precise cardiac health insights.
To test the employment, feasibility, clinical performance, and safety of HeartEye's ECG device, 594 patients admitted to the hospital will be enrolled for (near) simultaneous registration of a standard ECG and a HeartEye ECG for comparison of diagnosis by an independent expert panel of cardiologists to assess the degree of agreement. A HeartEye ECG can be performed within 60 seconds by simply holding the device against the chest without the use of adhesives, thereby causing minimal burden or risks for patients, if any.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 594 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients visiting a hospital that are scheduled for an ECG registration receive 1 additional ECG | – | Device: ECG registration with a handheld ECG device.Patients diagnosed with various conditions will be selected to create a diverse mixture of cardiac pathology in the following categories: 1. Normal, atypical cardiac complaints, extrasystole 2. Ischemic diseases 3. Arrhythmia, conduction delay 4. Cardiomyopathy 5. Pacemaker therapy 6. Systemic diseases (e.g., hypothyroidism, electrolyte disorder) Intervention: 1 additional ECG with a handheld ECG device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting a hospital with a known cardiac condition or complaints suspected of cardiac disease.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Patients visiting a hospital that are scheduled for an ECG registration receive 1 additional ECG |
Primary outcome
Primary Objective: To test non-inferiority, diagnostic agreement of the 12 lead HeartEye ECG will be determined by comparing individual cardiologist diagnosis per category to the traditional ECG.
Time frame: 4 months after first inclusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 38505481Zepeda-Echavarria A, van de Leur RR, Vessies M, de Vries NM, van Sleuwen M, Hassink RJ, Wildbergh TX, van Doorn JL, van der Zee R, Doevendans PA, Jaspers JEN, van Es R. Detection of acute coronary occlusion with a novel mobile electrocardiogram device: a pilot study. Eur Heart J Digit Health. 2024 Jan 17;5(2):183-191. doi: 10.1093/ehjdh/ztae002. eCollection 2024 Mar.
- Background: PubMed 38939006de Vries NM, Zepeda-Echavarria A, van de Leur RR, Loen V, Vos MA, Boonstra MJ, Wildbergh TX, Jaspers JEN, van der Zee R, Slump CH, Doevendans PA, van Es R. Detection of Ischemic ST-Segment Changes Using a Novel Handheld ECG Device in a Porcine Model. JACC Adv. 2023 Jul 19;2(5):100410. doi: 10.1016/j.jacadv.2023.100410. eCollection 2023 Jul.
- Individual participant dataSharing planned: Yes. ECG data. Patients characteristics. Questionnaires.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Abnormalities, Variable, run by HeartEye.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rien van der Zee, MD, PhD (+31 6 55756354, rien@hearteye.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective: To test non-inferiority, diagnostic agreement of the 12 lead HeartEye ECG will be determined by comparing individual cardiologist diagnosis per category to the traditional ECG. (time frame: 4 months after first inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07668089, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.