Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis
Caption Health, Inc.
Summary
This is a prospective clinical trial intended to capture echocardiographic images in patients clinically indicated for an echocardiographic examination using an additional Point of Care Ultrasound device . The images collected will be used to test and possibly validation an AI base Aortic Valve Stenosis algorithm
Description
This is a non-randomized, un-blinded single-arm study in patients scheduled for a standard echocardiographic examination. Participants will be scanned by a sonographer (Study Exam) and 6 standard views will be obtained using both the ultrasound systems: PLAX, PSAX-AV, AP4, AP2, AP3 and AP5 . The patient will undergo their scheduled echocardiographic examination either before or after the study examinations. The findings from the clinically indicated echocardiographic examination will be used as a gold standard for the presence/absence and severity of aortic stenosis. The first 45 patients,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients scheduled for an echocardiographic examination * Patients ≥18 years old * Patient with known or suspected valve disease based on medical history Exclusion Criteria: * Patients with artificial aortic valves * Unable to lie flat for study * Patients experiencing a known or suspected acute cardiac event * Patients unwilling or unable to give written informed consent
Interventions
- DeviceAutoAS
AutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study
Location
- Northwestern UniversityChicago, Illinois