HeartBeam Begins Study of its AIMIGo System

HeartBeam Inc. has enrolled the first patients in its VALID-ECG (Clinical Validation of the AIMIGo 12-Lead ECG Synthesis Software for Arrhythmia Detection) pivotal study. The first patients were enrolled at Atlanta Heart Specialists, a cardiology physician practice.
 
The VALID-ECG study will evaluate the performance of a 12-lead ECG synthesized from the credit card-sized HeartBeam AIMIGo system compared to a standard hospital-based 12-lead ECG using both quantitative and qualitative methodologies for assessing arrhythmias. HeartBeam AIMIGo leverages the company’s proprietary 3D vectorelectrocardiography (3D VECG) technology to capture signals in three projections (X, Y, Z) and synthesize a 12-lead ECG.
 
“We are thrilled to be part of this study as AIMIGo represents a significant leap in cardiac monitoring technology. It brings the power of 3D VECG into a familiar 12-lead ECG waveform, which is used to evaluate a range of cardiac conditions on a daily basis,” said David D. Suh, M.D., research director at Atlanta Heart Specialists. “The small form factor of AIMIGo makes it easy for patients to use the device whenever necessary. In addition, the clinical implications of 3D VECG technology could be potentially broad-ranging and extend to a variety of applications.”
 
The VALID-ECG Study will enroll 198 patients suffering from various underlying cardiac conditions at up to five U.S. sites. All patients enrolled in the study will receive simultaneously recorded ECGs from a standard 12-lead ECG machine and the HeartBeam AIMIGo system. The trial aims to demonstrate the equivalence of ECG waveforms between the AIMIGo synthesized 12-lead ECG and a standard 12-lead ECG by analyzing key ECG parameters called amplitudes and intervals. The study will also examine the accuracy of physician diagnosis for various arrhythmias with the AIMIGo synthesized 12-lead ECG compared to a standard 12-lead ECG. Enrollment in the study is expected to be completed this quarter.
 
HeartBeam’s 510(k) submission for the credit card-sized AIMIGo system is currently under reviewed by the U.S. Food and Drug Administration (FDA). This application is for the entire 3D VECG system, which consists of the AIMIGo device, the patient application, the physician portal, and the wireless communications between them. If cleared, the AIMIGo system would be the first handheld VECG system to be sanctioned by the FDA.
 
“The initiation of the VALID-ECG study is a major milestone for the company and a reflection of our commitment to provide a strong foundation of clinical data as we strive to provide patients and physicians with the ability to accurately monitor cardiac disease outside of a medical facility,” HeartBeam Founder/CEO Branislav Vajdic, Ph.D., said. “In addition, our product pipeline includes coupling AI with our data-rich 3D VECG technology which will enable us to extract unique information and longitudinal insights to transform how cardiac care is monitored in the future.”
 
The company has already completed an 80-patient pilot study using the same protocol as the VALID-ECG study. The company expects to present results at a scientific meeting in the second half of the year. 

HeartBeam’s proprietary vectorelectrocardiography (VECG) technology collects 3D signals of the heart’s electrical activity and converts them into a 12-lead ECG. This platform technology is designed to be used on portable, patient-friendly devices such as a credit-card sized monitor, watch or patch. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care—all outside of a medical facility.