Patients With an Indication for an Echocardiographic Examination With Suspicion of Valcular Heart Disease
Conditions
Brief 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
Detailed 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, 15 with mild, 15 with moderate and 15 with severe AS, will be used for testing and possible fine-tuning the AutoAS algorithm for each Study Device, and the remaining up to 155 patients for each Study Device will be used for clinical validation of the algorithm. Because these first 45 patients will only be used for possible fine-tuning the AutoAS algorithm, they will be excluded from endpoint analysis.
Interventions
DEVICEAutoAS
AutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study
Sponsors
Caption Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a prospective, non-randomized, un-blinded study in patients scheduled for a standard echocardiographic examination.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity | At the time of the examination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subgroup analysis of outcome 1 | At the time of the examination | Subgroup Analyses: Sensitivity and specificity will be calculated for the following sub-groups. BMI group (\< 25, ≥ 25-30, ≥ 30), sex, and age (\<65, ≥65) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAkhil Narang, MD
Northwestern University
Outcome results
None listed