Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis
NCT ID: NCT06717373
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-02-07
2025-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single Arm
There is no investigational device being used. Devices to be used are Vscan Air and Venue Ultrasound systems
AutoAS
AutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study
Interventions
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AutoAS
AutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study
Eligibility Criteria
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Inclusion Criteria
* Patients ≥18 years old
* Patient with known or suspected valve disease based on medical history
Exclusion Criteria
* Unable to lie flat for study
* Patients experiencing a known or suspected acute cardiac event
* Patients unwilling or unable to give written informed consent
18 Years
ALL
No
Sponsors
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Caption Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Akhil Narang, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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Central Contacts
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Other Identifiers
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CH_AutoAS_2024
Identifier Type: -
Identifier Source: org_study_id
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