Kosmos PLAX EF Pivotal Study
Public ClinicalTrials.gov record NCT07771231. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07771231
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 416 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 4, 2026
- Primary completion
- Aug 29, 2026
- Completion
- Sep 29, 2026
- Last update posted
- Aug 17, 2026
2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Memorial Healthcare System | Hollywood | Florida | 33021 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Heart Failure trials
Other public records listing Heart Failure. Sorted by last update posted; newest first. Not a recommendation.
- NCT07794930: Integrating Values Based Communication in Heart Failure Management Not yet recruiting
- NCT05585125: A Preliminary Study for INFORMED Recruiting
- NCT07232030: Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure Recruiting
- NCT06812533: Alleviant ALLAY-HFrEF Study Recruiting
- NCT05685303: Alleviant ALLAY-HF Study Recruiting
- NCT07220798: Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07771231, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 17, 2026 · Synced Aug 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07771231 live on ClinicalTrials.gov.