Trial is first of its kind to measure EF severity direct-from-ECG NEW YORK , July 24, 2024 /PRNewswire/ -- 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 CorTM 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.