Kosmos PLAX EF Pivotal Study

Overview

Key facts that identify this study and show where it stands today.

What the study is about and why it is being run, in the researchers' own words.

Official Title: Kosmos PLAX EF Pivotal Study
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.

The medical conditions and diseases this study investigates.

The treatments and procedures being evaluated in this study.

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Eligibility Criteria: 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.

How the study is designed and how its participant groups are organized.

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Where the study is run and whether each site is currently recruiting.

Memorial Healthcare System

Hollywood, Florida 33021, United States

The organizations and people involved in this study.

Other registered studies that closely resemble this one.