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

June 17, 2024 updated by: Rajiv Gulati, Mayo Clinic

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

400

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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

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
Experimental: Computerized Auscultation
Patients presenting to the echocardiogram laboratory for routine clinically indicated echocardiography or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures will undergo a computerized auscultation using the ©VoqX stethoscope and will have their heart sounds auscultated and recorded.
Device: ©VoqX stethoscope
Computerized auscultation detects both infrasound and audible sounds and is capable of amplifying auscultated sounds by a factor of thirty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
collecting computerized auscultation data in a time-efficient manner at the bedside is feasible
Time Frame: 2 years
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

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Rajiv Gulati, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

September 3, 2021

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-012844

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.

No

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.

Clinical Trials on Mitral Regurgitation

Clinical Trials on ©VoqX stethoscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe