AutoAS for Aortic Valve Stenosis

(POC Trial)

Overseen By Angeline Trinidad, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Caption Health, Inc.

Disqualifiers: Artificial aortic valves, Acute cardiac event, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Who Is on the Research Team?

Akhil Narang, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for an echocardiogram because they might have or are known to have valve disease, specifically aortic stenosis. It's not suitable for those who don't meet the age requirement or aren't already set to undergo this heart examination.

Inclusion Criteria

I have a history of heart valve problems.

I am scheduled for a heart ultrasound test.

Exclusion Criteria

Patients with artificial aortic valves

Patients unwilling or unable to give written informed consent

I cannot lie flat for medical procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Echocardiographic Examination

Participants undergo a standard echocardiographic examination and additional imaging with Point of Care Ultrasound devices for algorithm testing and validation

1 day

1 visit (in-person)

Algorithm Testing and Validation

The first 45 patients are used for testing and fine-tuning the AutoAS algorithm, while the remaining patients are used for clinical validation

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after the echocardiographic examination

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AutoAS

Trial Overview The trial is testing 'AutoAS', which is likely an AI-based algorithm designed to analyze ultrasound images of the heart. Participants will get additional scans with a Point of Care Ultrasound device during their regular echocardiography appointments.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Caption Health, Inc.

Lead Sponsor

Trials

6

Recruited

1,200+