Clinical Application of a New Handheld ECG Device (CANHED)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Abnormalities, Variable
• Intervention / Treatment: Device: ECG registration with a handheld ECG device.

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 Type: Observational
• Enrollment (Estimated): 594

Contacts and Locations

• Study Contact: Name: Rien van der Zee, MD, PhD; Phone Number: +31 6 55756354; Email: rien@hearteye.nl
• Study Contact Backup: Name: Tjebbe Tauber, MSc; Phone Number: +31 6 27190280; Email: tjebbe@hearteye.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients visiting a hospital with a known cardiac condition or complaints suspected of cardiac disease.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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: Normal, atypical cardiac complaints, extrasystole; Ischemic diseases; Arrhythmia, conduction delay; Cardiomyopathy; Pacemaker therapy; Systemic diseases (e.g., hypothyroidism, electrolyte disorder) Intervention: 1 additional ECG with a handheld ECG device.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	4 months after first inclusion.

Collaborators and Investigators

• Sponsor: HeartEye

Publications and helpful links

General 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.
• de 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): July 22, 2026
• Study Completion (Estimated): October 22, 2026

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 19, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Handheld ECG device
• Other Study ID Numbers: NL011365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: ECG data. Patients characteristics. Questionnaires.
• IPD Sharing Time Frame: Start date availability: Nov 30, 2026 for 15 years.
• IPD Sharing Access Criteria: Reviewers can access ECG data, patients characteristics, and questionnaires via the platform of the company's website. The key to a patient ID is stored separately in the participating hospitals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No