HeartBeam Enrolls 1st Patients in ALIGN-ACS Heart Attack Study

HeartBeam announced that the first patients were enrolled in its ALIGN-ACS study evaluating the HeartBeam system for heart attack detection. The first patients were enrolled by Prof. Dr. Vladan Vukcevic at the University Clinical Center of Serbia in Belgrade, Serbia.

A 12-lead ECG is the standard of care to diagnose a heart attack, but there’s no reliable method to assess possible heart attacks outside of the clinical setting. HeartBeam hopes to fill this gap and shorten “symptom-to-door” times by letting patients record a clinical-grade ECG the moment symptoms start.

HeartBeam’s ECG tech captures the heart’s electrical signals in 3D from three non-coplanar dimensions. This provides a high-fidelity, reliable way to evaluate possible heart attacks outside of the clinic.

“Every minute matters during a heart attack, and early, accurate identification of a heart attack is essential to ensuring patients receive the care they need in a timely manner and improving outcomes,” said HeartBeam Scientific Advisory Board Chair C. Michael Gibson, MD, FRCP, FAHA, FSCAI, FACC, Interventional Cardiologist at Beth Israel Lahey and Professor of Medicine at Harvard Medical School. “HeartBeam’s technology has the potential to meaningfully change how quickly we evaluate patients by providing timely access to clinical-grade ECG data outside the hospital, enabling clinicians to accelerate triage decisions and intervene sooner.”

The ALIGN-ACS pilot study will enroll 100 patients presenting with chest pain in the emergency room. Patients will be assessed with both a standard 12-lead ECG and the HeartBeam device and both results will be compared with each patient’s final diagnosis when they’re discharged.

The pilot study builds on earlier proof of concept studies showing a 3D ECG configuration similar to the HeartBeam device’s ability to spot heart attacks was of similar accuracy to a standard 12-lead ECG. Data from the ALIGN-ACS study will shape the design of a multicenter pivotal study to serve as the basis of a future U.S. Food and Drug Administration (FDA) submission.

“HeartBeam was founded on the premise that since most heart attacks happen outside of a hospital, there should be a fast and easy way for patients and physicians to assess both symptoms and ECG data at home or anywhere,” said Robert Eno, CEO for HeartBeam. “The initiation of our pilot study for heart attack detection is a defining moment for HeartBeam as this is one of the largest clinical opportunities in cardiology. Our platform is uniquely positioned to deliver clinical-grade ECG insights at the moment symptoms occur and facilitate more timely action to close the ‘symptom-to-door’ gap.”

In December, the company earned FDA 510(k) clearance for its 12-lead electrocardiogram (ECG) synthesis software to assess arrhythmias.