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

NCT ID: NCT04960280

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2026-04-30

Brief 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.

Detailed Description

In the current study the plan is to recruit 600 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.

Conditions

Isolated Aortic Stenosis; Mitral Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

©VoqX stethoscope

Intervention Type: DEVICE

Computerized auscultation detects both infrasound and audible sounds and is capable of amplifying auscultated sounds by a factor of thirty.

Interventions

©VoqX stethoscope

Computerized auscultation detects both infrasound and audible sounds and is capable of amplifying auscultated sounds by a factor of thirty.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Rajiv Gulati

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajiv Gulati, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

20-012844

Identifier Type: -

Identifier Source: org_study_id