Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCaption Health, Inc.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for an echocardiographic examination
Patients ≥18 years old
Patient with known or suspected valve disease based on medical history
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
AutoAS
DeviceAutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Single ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity and Specificity
The primary endpoints are the sensitivity and specificity of the Caption AutoAS algorithm for the absence (none/mild AS) or presence (moderate/severe AS) of AS relative to that indicated in the echocardiographic examination.
Time frame
At the time of the examinationSecondary outcomes
1
Subgroup analysis of outcome 1
Subgroup Analyses: Sensitivity and specificity will be calculated for the following sub-groups. BMI group (\< 25, ≥ 25-30, ≥ 30), sex, and age (\<65, ≥65)
Time frame
At the time of the examinationSponsors and contacts
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Source ClinicalTrials.gov