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HeartNCT07771231

Kosmos PLAX EF Pivotal Study

An observational study of Heart and Heart Failure, run by EchoNous Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Heart, Heart Failure, Ejection Fraction
What is being tested?
PLAX EF Manual vs. Automatic Measurement
Type of treatment
Medical device
How many people
416 participants
Where
1 siteUnited States
Study dates
5 May 2026to 30 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Healthcare System

    Hollywood, Florida, 33021

Other trials in United States

About this 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.

Being tested
PLAX EF Manual vs. Automatic Measurement
Keywords
Parasternal Long Axis Ejection Fraction, PLAX EF, LVEF, Teichholz formula, Teichholz method, Teichholz method for PLAX LVEF estimation, Kosmos, Kosmos Diagnostic Ultrasound System
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLAX EF Manual vs. Automatic MeasurementDevice

    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.

Study groups in NCT07771231
Study groupRoleWhat they receive
PLAX ClipsNot described
Receives: Device: PLAX EF Manual vs. Automatic Measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%.

    Measured: Following data acquisition (2 months)

  2. 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%.

    Measured: Following data acquisition (2 months)

Secondary outcomes (1)

  1. 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%.

    Measured: Following data acquisition (2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start5 May 2026
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07771231
Sponsor's protocol ID
ECHO-301
Status last verified
Aug 2026
First submitted
13 Aug 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: Publication decisions will be made at a later date.

Publications

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

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

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

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

  • 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.

    PubMed 35363499

  • 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.

    PubMed 1244736

  • 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.

    PubMed 25559473

Questions about this trial

What is this clinical trial studying?

An observational study of Heart and Heart Failure, run by EchoNous Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LVIDd Non-Inferiority Test (time frame: Following data acquisition (2 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07771231, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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