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Cardiovascular diseases (CVDs) are a global burden that requires attention. For the detection and diagnosis of CVDs, the 12-lead ECG is a key tool. With technological advancements, ECG devices are becoming smaller and available for home use. Most of these devices contain a limited number of leads and are aimed to detect atrial fibrillation (AF). To investigate whether a four-electrode arrangement could provide enough information to diagnose other CVDs, further research is necessary. At the University Medical Center Utrecht in a multidisciplinary team, we developed the miniECG, a four-electrode ECG handheld system for scientific research in clinical environments (TRL6). This paper describes the process followed during the development of the miniECG. From assembling a multidisciplinary team, which includes engineers, cardiologists, and clinical physicians to the contribution of team members in the design input, design, and testing for safety and functionality of the device. Finally, we detail how the development process was composed by iterative design steps based on user input and intended use evolution. The miniECG is a device compliant for scientific research with patients within Dutch Medical Centers. We believe that hospital-based development led to a streamlined process, which could be applied for the design and development of other technologies used for scientific research in clinical environments. [ABSTRACT FROM AUTHOR]

Aims: Many portable electrocardiogram (ECG) devices have been developed to monitor patients at home, but the majority of these devices are single lead and only intended for rhythm disorders. We developed the miniECG, a smartphone-sized portable device with four dry electrodes capable of recording a high-quality multi-lead ECG by placing the device on the chest. The aim of our study was to investigate the ability of the miniECG to detect occlusive myocardial infarction (OMI) in patients with chest pain., Methods and Results: Patients presenting with acute chest pain at the emergency department of the University Medical Center Utrecht or Meander Medical Center, between May 2021 and February 2022, were included in the study. The clinical 12-lead ECG and the miniECG before coronary intervention were recorded. The recordings were evaluated by cardiologists and compared the outcome of the coronary angiography, if performed. A total of 369 patients were measured with the miniECG, 46 of whom had OMI. The miniECG detected OMI with a sensitivity and specificity of 65 and 92%, compared with 83 and 90% for the 12-lead ECG. Sensitivity of the miniECG was similar for different culprit vessels., Conclusion: The miniECG can record a multi-lead ECG and rule-in ST-segment deviation in patients with occluded or near-occluded coronary arteries from different culprit vessels without many false alarms. Further research is required to add automated analysis to the recordings and to show feasibility to use the miniECG by patients at home., Competing Interests: Conflict of interest: P.A.D. and R.v.d.Z. own stock in HeartEye B.V., a company also active in the field of handheld ECG devices. R.R.v.d.L. and R.v.E. own stock in Cordys Analytics, a spin-off of the UMC doing ECG-AI analysis. The other authors have no conflicts of interest to declare., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)