AutoAS for Aortic Valve Stenosis

(POC Trial)

Overseen by Akhil Narang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Caption Health, Inc.

Disqualifiers: Artificial aortic valves, Acute cardiac event, others

No Placebo Group

Trial Summary

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.

Research Team

Akhil Narang, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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 am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• AutoAS (AI Algorithm)

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.

Participant Groups

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+