U.S., Aug. 19 -- ClinicalTrials.gov registry received information related to the study (NCT07771231) titled 'Kosmos PLAX EF Pivotal Study' on Aug. 13.
Brief Summary: The purpose of this study is to validate the efficacy of Kosmos PLAX EF, an AI-assisted workflow that uses a cardiac ultrasound clip in Parasternal Long Axis (PLAX) cardiac view to calculate Left Ventricular Ejection Fraction (LVEF) using the Teichholz method. This study will compare the algorithm-generated measurements to measurements performed by hand by expert echocardiographers. The primary objectives of the study are to demonstrate that the algorithm measurements are statistically interchangeable with measurements from a reference standard derived from human expert reader...