Clinical Application of a New Handheld ECG Device

NCT07668089 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: NL011365
• Study Type: observational
• Target: 594
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Handheld ECG device

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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.

Device: ECG registration with a handheld ECG device.

Interventions

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.

Patients visiting a hospital that are scheduled for an ECG registration receive 1 additional ECG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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).

Sponsors & Collaborators

• HeartEye: lead

Related Publications (2)

• 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.

  PMID: 38505481 BACKGROUND

• 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.

  PMID: 38939006 BACKGROUND

Central Study Contacts

Rien van der Zee, MD, PhD

CONTACT

+31 6 55756354; rien@hearteye.nl

Tjebbe Tauber, MSc

CONTACT

+31 6 27190280; tjebbe@hearteye.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 594 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 25, 2026
• Study Start: June 22, 2026
• Primary Completion: July 22, 2026
• Study Completion (Estimated): October 22, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start date availability: Nov 30, 2026 for 15 years.
• 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.