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 trial aims to improve the diagnosis of aortic valve stenosis (a condition where the heart's aortic valve narrows) using artificial intelligence. Researchers will collect ultrasound images of the heart to test an AI algorithm called AutoAS, designed to detect this condition more accurately. Individuals scheduled for an echocardiographic exam (a heart ultrasound) with known or suspected valve disease might be a good fit. The goal is to enhance the speed and accuracy of valve issue identification without using any experimental devices. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could transform heart disease diagnosis.

Will I have to stop taking my current medications?

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

What prior data suggests that this ultrasound device is safe for capturing echocardiographic images?

This study does not test any new treatments. Instead, existing ultrasound machines will capture images of the heart. These images will aid in developing an AI program to better understand aortic valve stenosis, a condition where the valve between the heart and the main artery narrows. Since no new treatments are being tested, there are no safety concerns about new devices or medications. The ultrasound machines used, Vscan Air and Venue Ultrasound systems, are common in medical imaging. They are generally safe and regularly used in hospitals and clinics. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AutoAS for treating aortic valve stenosis because it leverages advanced ultrasound technology to potentially improve diagnostic accuracy and patient monitoring. Unlike traditional treatments like valve replacement surgery, AutoAS focuses on using Vscan Air and Venue Ultrasound systems to better assess the condition of the aortic valve without invasive procedures. This non-invasive approach could lead to earlier interventions and more personalized treatment plans, offering a promising alternative to conventional methods.

What evidence suggests that this AI-based algorithm is effective for Aortic Valve Stenosis?

Research has shown that patients with severe aortic stenosis, a narrowing of a heart valve, achieve good outcomes with procedures like Transcatheter Aortic Valve Replacement (TAVR) or surgery. Studies indicate that after five years, patients who underwent TAVR or surgery had similar survival rates and risk of serious stroke, demonstrating that both treatments are equally effective for severe aortic stenosis. Without treatment, severe aortic stenosis can lead to high death rates, emphasizing the necessity of intervention. Although the AutoAS trial does not test a new treatment, understanding these results underscores the importance of accurate diagnosis and management to improve patient health. ^{6 7 8 9 10}

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+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.036657

Clinical Outcomes According to Aortic Stenosis Management Patients with untreated severe AS experienced high mortality rates, mostly cardiovascular for patients who declined AVR.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12167023/

Paradoxical clinical outcomes of severe versus very ... After transcatheter valve implantation (TAVI) outcomes seem to be similar or – paradoxically – even better compared to severe aortic stenosis (SAS), as ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.004

5-Year Outcomes After Transcatheter or Surgical Aortic ... At 5 years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0735109725053355

5-Year Outcomes After Transcatheter or Surgical Aortic ... At 5 years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke.

5. jscai.org jscai.org/article/S2772-9303(24)01365-6/fulltext

Long-Term Outcomes of Transcatheter vs Surgical Aortic ... Overall, no significant difference in death or disabling stroke was observed with TAVR vs SAVR (HR, 1.02; 95% CI, 0.93-1.11; P = .70). Mortality ...

6. ahajournals.org ahajournals.org/doi/10.1161/JAHA.125.041283

Early Aortic Valve Replacement of Asymptomatic Severe ... Asymptomatic severe aortic stenosis may lead to the progression to both symptoms and adverse outcomes if left untreated. The appropriate timing ...

7. mayoclinic.org mayoclinic.org/diseases-conditions/aortic-stenosis/symptoms-causes/syc-20353139

Aortic valve stenosis - Symptoms and causes This type of heart valve disease reduces or blocks blood flow from the heart to the body. Know the symptoms and how it's treated.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12304764/

The Association of Aortic Stenosis Severity and Symptom ... Patients with symptomatic moderate AS had a similar risk to those with severe AS without symptoms (adjusted HR: 1.77 [95% CI: 1.65-1.91] vs 1.81 ...

9. heart.org heart.org/en/health-topics/heart-valve-problems-and-disease/heart-valve-problems-and-causes/problem-aortic-valve-stenosis

Aortic Stenosis Overview Aortic stenosis (or AS) is a narrowing of the aortic valve opening. Learn how it affects the heart valve and what you can do about it.

10. jacc.org jacc.org/doi/10.1016/j.jcmg.2021.05.027

Considering the Hazards of Aortic Valve Stenosis We have long known that symptomatic severe aortic valve stenosis (AS) is associated with a poor prognosis if aortic valve intervention is ...