Study for the Assessment of the Quality of Echocardiographic Clips.

Launched by ULTRASIGHT · Oct 11, 2021

Keywords

ClinConnect Summary

This pivotal study is a multi-center, multi-reader multi-case (MRMC) study, designed to assess the quality of the clips obtained by novice users when using the UltraSight AI Guidance software. Prior to the study start, there will be a pre-study training phase for training the novice users.

During the study, eligible subject will undergo the echocardiography examination twice on a single study visit (same day): once by one of the novice users when using the UltraSight AI Guidance software, and once by an expert sonographer without the aid of the software.

Each novice user will perform the ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 and older
• • 2. Subjects willing and able to give written informed consent.
• Exclusion Criteria:
• • 1. Emergency (non-elective) admission within 24 h prior to participating in the study
• • 2. Female subjects who are pregnant (women of childbearing potential will perform a urine pregnancy test)
• • 3. Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
• • 4. Subjects who currently participate a clinical trial, involving interventional cardiac devices.
• • 5. Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report
• • 6. Subjects with BMI above 40
• • 7. Subjects experiencing a known or suspected acute cardiac event
• • 8. Subjects with severe chest wall deformity as per previous medical records and physical examination
• • 9. Subjects who have undergone pneumonectomy
• • 10. Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e. situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).
• • A woman is of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis.).