NCT07771231Active, not recruiting
Kosmos PLAX EF Pivotal Study
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 416 (actual)
- First submitted
- 13 Aug 2026
- Start date
- 5 May 2026
- Primary completion date
- 30 Aug 2026
- Lead sponsor
- EchoNous Inc.
- Diseases
- Heart failure
- NCT number
- NCT07771231
What you commit to
- Study type: Observational
- Participants enrolled: 416
- From 5 May 2026 to the primary completion date, 30 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Inadequate demographic information corresponding to the available data, and
- Non-echocardiographer acquired images.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Healthcare System Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.