A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease

Mitral Regurgitation Clinical Trial

Official title:

Use of a Computerized Body Auscultation Device (©VoqX) for the Diagnosis of Structural Cardiac Pathologies

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04960280
• Other study ID #: 20-012844
• Status: Suspended
• Phase: N/A
• Start date: September 3, 2021
• Est. completion date: July 2024

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In the current study the plan is to recruit 400 patients who have been 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 structure and sounds, isolated aortic stenosis (of varying severity), and isolated mitral regurgitation (of varying severity) will be included, while excluding individuals who have multiple valve involvements or combined valve pathologies. Each patient will have baseline testing using the ©CompuSteth device, which will be used to auscultate and record each patient's heart sounds at the bedside prior to the index echocardiogram or cardiac catheterization procedure. This process will take less than 10 minutes and is outlined below. Patients will then proceed with their clinically indicated echocardiograms or cardiac catheterization procedures.

Amongst the first 200 study participants, the results of the echocardiograms and invasive cardiac catheterization procedures will be used to train the ©VoqX device to identify normal heart and to screen and grade for various cardiac structural pathologies, aortic stenosis, and mitral regurgitation, diagnosed by gold-standard testing. Subsequently, after the ©VoqX device has been trained how to characterize and identify sounds that correspond to various structural cardiac pathologies, the next step is to prospectively 'test' how well the ©VoqX device is able to screen normal heart from cardiac pathologies, such as aortic stenosis, and mitral regurgitation, and identify the severity of the valve disorder in the subsequent 200 participants of the study. This will be done by comparing the results obtained from auscultation with the ©VoqX device against the results obtained from gold-standard testing with echocardiography or invasive cardiac catheterization.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• ©VoqX stethoscope
Computerized auscultation detects both infrasound and audible sounds and is capable of amplifying auscultated sounds by a factor of thirty.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials