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Kosmos Trio and Ejection Fraction Pivotal Study

NCT06027164 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 153

Last updated 2024-05-21

No results posted yet for this study

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

Conditions

  • Cardiac Disease

Interventions

DEVICE

Portable Ultrasound System

EchoNous KOSMOS

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-04
Primary Completion
2023-08-31
Completion
2024-05-16
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027164 on ClinicalTrials.gov