Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis

NCT06717373 | Recruiting FDA Device

• 1 other identifier: CH_AutoAS_2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patients with an Indication for an Echocardiographic Examination with Suspicion of Valcular Heart Disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity

  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 Outcomes (1)

• Subgroup analysis of outcome 1

  At the time of the examination

Study Arms (1)

Single Arm

OTHER

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

Device: AutoAS

Interventions

AutoAS DEVICE

AutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for an echocardiographic examination
• Patients ≥18 years old
• Patient with known or suspected valve disease based on medical history

You may not qualify if:

• 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

Sponsors & Collaborators

• Caption Health, Inc.: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60208, United States

RECRUITING

Study Officials

• Akhil Narang, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yngvil K Thomas, MSc

CONTACT

+1 312-316-5632; yngvil.thomas@gehealthcare.com

Angeline Trinidad, BA

CONTACT

+1 310-940-9162; Angeline.Trinidad@gehealthcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, non-randomized, un-blinded study in patients scheduled for a standard echocardiographic examination.

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: December 5, 2024
• Study Start: February 7, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)