Abstract 15392: Performance of a Novel Unshielded Magnetocardiography Device in a First-in-Human Study

Abstract

Background: Magnetocardiography (MCG) is a non-contact measurement of magnetic fields generated by the heart’s electrical currents, represented by Magnetic Field Maps (MFMs). It is effective in detecting coronary ischemia and NSTEMI. Despite the advantages of MCG, adoption has been limited due to poor usability and high costs. We designed and built a novel bedside MCG device that measures cardiac magnetic fields without the limitations of magnetic shielding or cryogenics, and tested the performance of this prototype at a hospital in a first-in-human study. Objective: We aimed to characterize the safety and technical feasibility of the device, prominence of cardiac features in the average waveforms, and evaluate background interference rejection. Methods: We enrolled 26 participants (73% Age >=55, 54% Male, 85% White) at intermediate to high risk for CAD scheduled for cardiac testing (ECG, stress test, CTA, or cardiac catheterization) as part of standard clinical care at an urban hospital. On the day of testing, all participants received a 15-minute MCG scan and a reference 12-lead ECG simultaneously. Participants were contacted 7 days later for a safety assessment. Study staff were trained for 1 hour on device operation. Results: Of the 26 MCG scans, 23 (88%) showed cardiac features such as QRS complex and T-waves. The average signal-to-noise ratio (SNR) of the QRS complex was 11 (SD = 6), and the average T-wave SNR was 3.6 (SD = 2). The device effectively rejected background interference >1000x larger than cardiac signals. No adverse device effects were reported. Conclusions: The device successfully captured cardiac signals in a magnetically noisy hospital environment. The SNR level indicates the device has the potential to generate MFMs with future capability of classifying disease states. The device’s non-contact operation, quick set-up, and bedside ease of use enables wider adoption of MCG in the clinic.