Mitral Regurgitation Clinical Trial
Official title:
Use of a Computerized Body Auscultation Device (©VoqX) for the Diagnosis of Structural Cardiac Pathologies
NCT number | NCT04960280 |
Other study ID # | 20-012844 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | September 3, 2021 |
Est. completion date | July 2024 |
Verified date | June 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether recording heart sounds with an acoustic stethoscope, combined with artificial intelligence (computer information), will show similar abnormalities to an echocardiogram or cardiac catheterization.
Status | Suspended |
Enrollment | 400 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - Aged 18 years of age or older. - Referred to the echocardiogram laboratory for routine clinically indicated echocardiography, or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures - Individuals with normal heart sounds, isolated aortic stenosis (any degree of severity), or isolated mitral regurgitation (any degree of severity) Exclusion Criteria - Patients with unstable cardiovascular or pulmonary disease - Patients with mixed valvular heart disease, corresponding to more than one type of valve pathology (i.e.: Aortic stenosis and Aortic Regurgitation), or more than 1 valve involved (i.e.: aortic stenosis and mitral regurgitation) |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | collecting computerized auscultation data in a time-efficient manner at the bedside is feasible | i) As part of the initial part of the study, that collecting computerized auscultation data using the ©CompuSteth device from patients presenting to the echocardiogram laboratory for routine clinically indicated echocardiography, or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures in a time-efficient manner at the bedside is feasible. Further, that we can successfully train the ©CompuSteth device to screen for normal heart structure and sounds as well as for a variety of structural cardiac pathologies, including aortic stenosis and its severity, and mitral regurgitation and its severity, using echocardiography or invasive cardiac catheterization as gold standard testing for the presence or absence of structural cardiac pathologies | 2 years |
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