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NCT Number: NCT07771231

Kosmos PLAX EF Pivotal Study

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Cardiovascular Diseases Ejection Fraction Heart Diseases Heart Failure Left Ventricular Ejection Fraction Left Ventricular Ejection Fraction Less Then or Equal to 50percent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PLAX EF Manual vs. Automatic Measurement

Device

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.

Primary outcomes

  1. LVIDd Non-Inferiority Test

    Time frame: 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%.

  2. LVIDs Non-Inferiority Test

    Time frame: 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 outcomes

  1. EF Non-Inferiority Test

    Time frame: 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%.

Sponsors and collaborators

Lead sponsor

EchoNous Inc.

Industry

Collaborators

  • Memorial Healthcare System

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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