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

July 13, 2026 updated by: Caption Health, Inc.
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60208
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
There is no investigational device being used. Devices to be used are Vscan Air and Venue Ultrasound systems
Device: AutoAS
AutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: At the time of the examination
The primary endpoints are the sensitivity and specificity of the Caption AutoAS algorithm for the absence (none/mild AS) or presence (moderate/severe AS) of AS relative to that indicated in the echocardiographic examination.
At the time of the examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroup analysis of outcome 1
Time Frame: At the time of the examination
Subgroup Analyses: Sensitivity and specificity will be calculated for the following sub-groups. BMI group (< 25, ≥ 25-30, ≥ 30), sex, and age (<65, ≥65)
At the time of the examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caption Health, Inc.

Investigators

  • Principal Investigator: Akhil Narang, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2025

Primary Completion (Actual)

May 16, 2025

Study Completion (Actual)

May 16, 2025

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH_AutoAS_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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