Ejection Fraction, Heart, Heart Failure, Left Ventricular Ejection Fraction, Left Ventricular Ejection Fraction Less Then or Equal to 50percent
Conditions
Keywords
Parasternal Long Axis Ejection Fraction, PLAX EF, LVEF, Teichholz formula, Teichholz method, Teichholz method for PLAX LVEF estimation, Kosmos, Kosmos Diagnostic Ultrasound System
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 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.
Interventions
DEVICEPLAX EF Manual vs. Automatic Measurement
All de-identified PLAX (Parasternal Long Axis) echocardiographic clips, along with corresponding demographic information, was collected from previously collected datasets. No additional imaging, interventions, or participant contact was performed as part of this study. Three independent, board-certified expert readers, blinded to automated outputs and to each other's assessments, manually measured LVIDd and LVIDs following ASE guidelines to produce the Reference Standard Measurements. The Kosmos EF algorithm processed each clip to generate automated LVIDd, LVIDs, and computed EF measurements to create the Automated Measurements. Automated measurements were compared to reference standard using an MAE-based methodology.
Sponsors
EchoNous Inc.
Memorial Healthcare System
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Inadequate demographic information corresponding to the available data, and * Non-echocardiographer acquired images.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LVIDd Non-Inferiority Test | 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 | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EF Non-Inferiority Test | Following data acquisition (2 months) | EF will be computed from the automated LVIDd and LVIDs measurements using the Teicholz formula. The computed EF will be compared to the reference standard EF using the MAE-based methodology. Using the Mean Absolute Error (MAE) methodology, the computed EF 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%. |
Countries
United States
Outcome results
None listed