An observational study in Heart, Heart Failure and Ejection Fraction, sponsored by EchoNous Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by EchoNous Inc. · Observational
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 416 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →EchoNous Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study used retrospective datasets from 2 sources: ECHO-004 and PLAX LVEF Data Collection studies. Both datasets comprise fully de-identified, retrospective, echocardiographic, PLAX-view clips acquired using the Kosmos diagnostic ultrasound system.
Data collection for the ECHO-004 study was performed at Revival Research Institute (Dearborn, Michigan). PLAX LVEF Data Collection was performed at Memorial Healthcare System (Hollywood, Florida). Source data was collected targeting a balanced representation of demographics and clinical characteristics (including normal and low ejection fraction) to ensure the generalizability of study findings.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: PLAX 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.
LVIDd Non-Inferiority Test
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%.
Time frame: Following data acquisition (2 months)
LVIDs Non-Inferiority Test
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%.
Time frame: Following data acquisition (2 months)
EF Non-Inferiority Test
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%.
Time frame: Following data acquisition (2 months)
Plan to share: Undecided — Publication decisions will be made at a later date.
Started May 2026 (actual). Primary completion is estimated for Aug 2026, 3 months after the start.
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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EchoNous Inc.