Kosmos Trio and Ejection Fraction Pivotal Study

Study Overview
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Brief Summary
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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

Official Title
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Kosmos Trio and Ejection Fraction Pivotal Study

Conditions
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Cardiac Disease

Intervention / Treatment
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* Device: Portable Ultrasound System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Subjects<br>Ultrasound scans conducted by novice users and experts on this cohort. | Device: Portable Ultrasound System<br>* EchoNous KOSMOS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments | 
| Manual vs. KOSMOS-EF for Sonographer Scans | Measurements are computed for A4C and A2C scans acquired by sonographers . We will compare KOSMOS-EF LVEF calculation to LVEF calculated by a panel of cardiologists via a majority vote. | Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments | 
| Assessment of Left Atrial 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 Left Atrial Size. | Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments |