Kosmos Trio and Ejection Fraction Pivotal Study

EchoNous Inc.153 enrolled

Overview

This is a single-group, observational study which will involve obtaining two echo scans of recruited patients. All recruited patients will undergo echo scans by both novice users (nurses) and experts (echo sonographers). Image quality between novices and experts as well as the ability to calculate LVEF from novice and expert scans and the quality of the LVEF calculated via KOSMOS-EF compared to LVEF calculations by expert cardiologists will occur in post-hoc Echo image analysis

Study Type

OBSERVATIONAL

Enrollment

153

Conditions

Cardiac Disease

Interventions

Portable Ultrasound SystemDEVICE

EchoNous KOSMOS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18-89 years of age * Have capacity to provide written consent either themselves or via healthcare proxy as determined by subjects' clinical care teams * Have an anticipated timeline in the EDOU long enough to allow for completion of study procedures without causing delay to subjects' usual clinical care Exclusion Criteria: * Heart rate \> 110 beats per minute at the time of recruitment * Pregnant women * Prior chest surgery * Chest wall deformities or injuries (i.e. wounds, infections, etc) * Limited mobility precluding them from turning in bed independently * Speak a primary language other than English or Spanish * Vulnerable populations including: patients being evaluated for psychiatric crises, incarcerated individuals * Unwilling or unable to consent to study procedures

Locations (1)

Revival Research Institute LLC

Dearborn, Michigan, United States

Outcomes

Primary Outcomes

Assessment of Global Left Ventricular Function

A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurses is of sufficient image quality to make a qualitative visual assessment of the Global Left Ventricular Function.

Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

Assessment of Left Ventricular Size

A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of the Left Ventricular Size.

Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

Assessment of Non-Trivial Pericardial Effusion

A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Non-Trivial Pericardial Effusion.

Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

Assessment of Right Ventricular Size

A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Right Ventricle Size.

Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

Secondary Outcomes

Assessment of Automatic Structure Labelling

A panel of cardiologists will access and determine via a majority vote if the frame-level false discovery rate (FDR) of automated cardiac structure labeling as determined by expert cardiologists for scans acquired by cardiac sonographers.

Data from ClinicalTrials.gov

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