Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis (POC)

Caption Health

Status: Enrolling

Conditions: Patients with an Indication for an Echocardiographic Examination with Suspicion of Valcular Heart Disease

Treatments: Device: AutoAS

Study type: Interventional

Funder types: Industry

Identifiers

NCT06717373

CH_AutoAS_2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Single Arm

Other group

Description:

There is no investigational device being used. Devices to be used are Vscan Air and Venue Ultrasound systems

Treatment:

Device: AutoAS