Kosmos Trio and Ejection Fraction Pivotal Study

Completed

Conditions studied: Cardiac Disease

In brief

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

Key facts

Study ID

NCT06027164

Run by

EchoNous Inc.

People needed

153

Starts

2023-08-04

Expected to finish

2024-05-16

Last updated by the study team

2024-05-21

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Revival Research Institute LLC — Dearborn, Michigan, United States

Full record on ClinicalTrials.gov

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