Kosmos Trio and Ejection Fraction Pivotal Study

Cardiac Disease Clinical Trial

Official title:

Kosmos Trio and Ejection Fraction Pivotal Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06027164
• Other study ID #: ECHO-004
• Status: Active, not recruiting
• Start date: August 4, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: September 2023
• Source: EchoNous Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 153
• Est. completion date: October 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Device:
• Portable Ultrasound System
EchoNous KOSMOS

Locations

Country	Name	City	State
United States	Revival Research Institute LLC	Dearborn	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
EchoNous Inc.	Centaur Labs, Revival Research Institute LLC, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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