Peerbridge Health today announced the beginning of enrollment for its Ejection Fraction AI-enabled Clinical Trial (EF-ACT) pivotal trial to determine Left Ventricular Ejection Fraction (LVEF) severity directly from its AI-enabled Peerbridge Cor™ remote wearable electrocardiogram (ECG) device. This will enable on-demand assessments of EF Severity on the American Society of Echocardiography scale and will be available anytime in all settings – in clinic and at home.
Ejection Fraction Severity categories help clinicians assess the severity of heart dysfunction, guiding treatment decisions and prognostic evaluations. The Ejection Fraction (EF) severity categories on the American Society of Echocardiography (ASE) scale are defined based on the percentage of blood that the left ventricle pumps out with each contraction.
The trial, whose announcement comes following in-depth discussions with leading cardiology experts and the Food and Drug Administration, will involve approximately 1,000 patients across multiple trial centers, including Northwell Health, Hackensack Meridian Health, Mount Sinai Health System, LeBauer-Brodie Center for Cardiovascular Research at Cone Health and Orange County Heart Institute in California. This pivotal trial comes on the heels of a successful feasibility trial in 2023.
“This is the first pivotal trial to study direct-from-ECG ejection fraction (EF) severity at this level of fidelity. The findings of this trial could have a profound effect on access and affordability of cardiac care.”
Chris Darland, Peerbridge Health CEO and President
Echocardiograms are the most common measurement tool for ejection fraction, but they must be performed in a clinic or hospital setting. This can pose challenges due to delays in scheduling, limited staffing resources, lack of access, and higher costs. The Peerbridge Health platform offers a seamless remote monitoring option that is less expensive, reducing patient burden and enabling more frequent assessments. Coupled with rhythm changes, direct-from-COR EF Severity would add valuable context for clinical decision-making, enhancing intervention adjustments.
“Peerbridge’s EF technology addresses a critical gap in remote healthcare by providing a rapid, convenient, noninvasive, and cost-effective method to better understand a patient’s cardiac status. Early and accurate remote detection of potential cardiac dysfunction allows us to intervene more quickly and more effectively, improving patient outcomes at a fraction of the cost.”
Nicolas Skipitaris, MD, Chairman of Cardiovascular Medicine at Northwell Health’s Westchester Hospitals
Development of the Peerbridge Health Advanced Diagnostics platform began in Spring 2023 and Ejection Fraction Severity is the first of three AI-enabled pivotal trials for Software-as-a-Medical Device (SaMD), with Heart Failure Detection and Sleep Apnea Diagnosis to follow.
“We’re very grateful to our clinical partners and are focused on continuing to deliver innovation to care providers across the country. Our goal remains to reach the millions of aging patients who don’t have the luxury of time or money to proactively see a cardiologist to avoid a losing battle with heart disease. The team at Peerbridge takes this responsibility seriously. I am confident that our technology will provide meaningful impact in the near- and long-term.”
Chris Darland, Peerbridge Health CEO and President
