Actively Recruiting
Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis
Led by Caption Health, Inc. · Updated on 2025-02-12
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a clinical trial to evaluate the use of echocardiographic imaging in patients who need an echocardiographic exam due to known or suspected valve disease. The study aims to test and possibly validate an artificial intelligence algorithm called AutoAS, designed to detect aortic valve stenosis using images from a Point of Care Ultrasound device. This research is a non-randomized, un-blinded single-arm study focusing on patients scheduled for a standard echocardiographic examination. Participants will undergo additional scans by a sonographer using two ultrasound systems, Vscan Air and Venue Ultrasound, to capture six standard views: PLAX, PSAX-AV, AP4, AP2, AP3, and AP5. Their routine clinical echocardiographic exam will happen either before or after these study scans. The first 45 patients, grouped by mild, moderate, or severe aortic stenosis, will help fine-tune the AutoAS algorithm, while up to 155 additional patients will be used to validate the algorithm clinically. During the study, researchers will compare the AI algorithm's results to the findings from the routine exam to measure its accuracy in identifying aortic stenosis. Participants will have their heart images taken and evaluated, and the main outcomes measured are the sensitivity and specificity of the algorithm at the time of examination. The study will continue until April 2025, with ongoing assessments to support the development of this AI tool for heart valve disease evaluation.
CONDITIONS
Brief Title
Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for an echocardiographic examination
- Patients 65 18 years old
- Patient with known or suspected valve disease based on medical history
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Duration - Same day as scheduled clinical examination
Participants undergo a study echocardiographic examination performed by a sonographer using two ultrasound systems to acquire 6 standard views. This is done alongside their scheduled clinical echocardiographic examination.
1 visit (in-person) including both study and clinical echocardiographic exams
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60208
Actively Recruiting
Research Team
Y
Yngvil K Thomas, MSc
A
Angeline Trinidad, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Frequently Asked Questions
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