SHAPE:SeeingtheHeartwithAIPoweredEcho

Completed · Not applicable

Conditions studied: Cardiac Disease

In brief

Establish transthoracic echocardiogram (TTE) exams performed with Bay Labs EchoGPS guidance technology can be used in a primary care setting to accurately identify cardiac disease. In Phase I TTE exams with EchoGPS will be compared to findings from a commercially available, FDA 510(k)-cleared reference device (Terason uSmart 3200t, point-of-care ultrasound) without EchoGPS assistance technology. Study is non-significant risk (NSR).

Key facts

Study ID

NCT03705650

Run by

Sara Guttas

People needed

55

Starts

2018-10-10

Expected to finish

2019-09-06

Last updated by the study team

2020-03-23

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients indicated for a standard physical examination
• Patients ≥65 years old
• For patients in Phase I, one of the following additional inclusion criteria must be present:
• Patient presenting with a new murmur, or history of a murmur but no prior echo within 3 years of the exam
• Patient presenting with shortness of breath
• Unexplained pedal edema

You may not qualify if…

• Unable to lie flat for study
• Significant anatomical abnormality, recent trauma, or recent thoracic/abdominal surgery that would limit the ability to obtain adequate images
• Subjects unwilling or unable to give written informed consent
• Patients experiencing a known or suspected acute cardiac event Eligibility criteria for Phases II and III of this study will be finalized once results from Phase I are available. The current plan is to have similar criteria for Phases II and III.

Where it is running

• Northwestern Memorial, Central DuPage — Winfield, Illinois, United States

Full record on ClinicalTrials.gov

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