Kosmos PLAX EF Pivotal Study

NCT07771231 | Active Not Recruiting FDA Device

• 1 other identifier: ECHO-301
• Study Type: observational
• Target: 416
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Parasternal Long Axis Ejection Fraction; PLAX EF; LVEF; Teichholz formula; Teichholz method; Teichholz method for PLAX LVEF estimation; Kosmos; Kosmos Diagnostic Ultrasound System

Outcome Measures

Primary Outcomes (2)

• 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%.

  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%.

  Following data acquisition (2 months)

Secondary Outcomes (1)

• EF Non-Inferiority Test

  Following data acquisition (2 months)

Study Arms (1)

PLAX Clips

Device: PLAX EF Manual vs. Automatic Measurement

Interventions

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.

PLAX Clips

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Inadequate demographic information corresponding to the available data, and
• Non-echocardiographer acquired images.

Sponsors & Collaborators

• EchoNous Inc.: lead
• Memorial Healthcare System: collaborator

Study Sites (1)

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Related Publications (7)

• ICH Harmonised Guideline. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). 2016.

  BACKGROUND

• Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed. Chapman & Hall/CRC; 2008.

  BACKGROUND

• FDA. Collection of Race and Ethnicity Data in Clinical Trials: Guidance for Industry and FDA Staff. 2016.

  BACKGROUND

• FDA. Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests: Guidance for Industry and FDA Staff. 2007

  BACKGROUND

• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

  PMID: 35363499 BACKGROUND

• Teichholz LE, Kreulen T, Herman MV, Gorlin R. Problems in echocardiographic volume determinations: echocardiographic-angiographic correlations in the presence of absence of asynergy. Am J Cardiol. 1976 Jan;37(1):7-11. doi: 10.1016/0002-9149(76)90491-4.

  PMID: 1244736 BACKGROUND

• Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.

  PMID: 25559473 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: May 5, 2026
• Primary Completion: August 30, 2026
• Study Completion: September 30, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

US (1)