Kosmos PLAX EF Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- LVIDd Non-Inferiority Test
研究概览
简要总结
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 readers. The primary hypotheses are that the algorithm measurements of left ventricular internal dimensions at 1) end-diastole (LVIDd) and 2) end-systole (LVIDs), respectively, will be statistically non-inferior to the reference standard. The secondary objective is to demonstrate that the algorithm-calculated LVEF is statistically interchangeable with the LVEF calculated by human readers. The secondary hypothesis is that the LVEF calculated from algorithm measurements will be statistically non-inferior to the reference standard. The study design involves the compilation of de-identified, retrospective PLAX-view clips acquired using the Kosmos diagnostic ultrasound system. This data was collected from two previous studies, and was not used in the training of the PLAX EF AI algorithm, or in the ECHO-300 PLAX EF pilot study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All data used in this study must have been collected per 45 CFR § 26,
- •Data must have been collected per source protocol requirements with no deviation for that data set,
- •Adequate demographic information available from original study participation (sex, BMI, ethnicity, and race),
- •PLAX acquisition performed by a qualified echocardiographer using the Kosmos system, and
- •At least one PLAX clip available.
排除标准
- •Inadequate demographic information corresponding to the available data, and
- •Non-echocardiographer acquired images.
结局指标
主要结局
LVIDd Non-Inferiority Test
时间窗: Following data acquisition (2 months)
A panel of three expert readers will independently measure LVIDd on each study clip. The automated LVIDd measurement will be compared to the reference standard using MAE. Using the Mean Absolute Error (MAE) methodology, the automated LVIDd measurement error relative to expert readers will be non-inferior to human inter-reader variability, defined as the upper bound of the 95% bootstrap confidence interval for the median relative MAE difference being less than +25%.
LVIDs Non-Inferiority Test
时间窗: Following data acquisition (2 months)
A panel of three expert readers will independently measure LVIDs on each study clip. The automated LVIDs measurement will be compared to the reference standard using the MAE-based methodology. Using the Mean Absolute Error (MAE) methodology, the automated LVIDs measurement error relative to expert readers will be non-inferior to human inter-reader variability, defined as the upper bound of the 95% bootstrap confidence interval for the median relative MAE difference being less than +25%.
次要结局
- EF Non-Inferiority Test(Following data acquisition (2 months))