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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | There is no investigational device being used. Devices to be used are Vscan Air and Venue Ultrasound systems |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AutoAS | Device | AutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the time of the examination |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | At the time of the examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yngvil K Thomas, MSc | Contact | +1 312-316-5632 | yngvil.thomas@gehealthcare.com | |
| Angeline Trinidad, BA | Contact | +1 310-940-9162 | Angeline.Trinidad@gehealthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Akhil Narang, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Recruiting | Chicago | Illinois | 60208 | United States |
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This is a prospective, non-randomized, un-blinded study in patients scheduled for a standard echocardiographic examination.
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