Computerized Stethoscope for Heart Disease

Overseen By Anna Pick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Unstable cardiovascular, pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests special computerized stethoscopes, including the ©CompuSteth and ©VoqX stethoscopes, to determine if they can detect heart problems as effectively as more complex tests like echocardiograms or heart catheterizations. The trial includes individuals already undergoing these heart tests and focuses on those with normal heart sounds or specific conditions such as aortic stenosis (narrowing of the heart's aortic valve) or mitral regurgitation (leakage in the heart's mitral valve). It excludes individuals with unstable heart or lung diseases or multiple valve issues. As an unphased trial, this study offers participants the chance to contribute to innovative research that could simplify heart diagnostics.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the computerized stethoscope is safe for heart disease diagnosis?

Research has shown that the VoqX stethoscope safely records heart sounds using advanced technology. One study recorded heart sounds from 100 patients without any safety issues, suggesting the device is generally well-tolerated. The VoqX stethoscope combines electronic components and software to detect heart sounds more effectively. So far, no significant problems have been reported with its use.

This computerized stethoscope aims to match the accuracy of more complex tests like echocardiograms, but without the associated risks. Since the trial compares heart sound recordings to these tests, it does not involve new medicines or invasive tools. Therefore, participants using the VoqX stethoscope face relatively low safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the computerized stethoscope trial because it could transform how heart disease is detected and monitored. Unlike traditional stethoscopes that rely on a doctor's ear, the ©VoqX stethoscope uses advanced technology to record and analyze heart sounds digitally. This could lead to more accurate diagnoses and help identify heart issues earlier by picking up subtle abnormalities that might be missed otherwise. Additionally, the potential for data sharing and analysis through computerized means offers a new layer of insight that could improve patient outcomes significantly.

What evidence suggests that the ©CompuSteth and ©VoqX stethoscopes are effective for detecting heart disease?

Research has shown that the VoqX stethoscope, which uses artificial intelligence, can help detect serious heart problems such as aortic stenosis (a narrowing of the heart's aortic valve). In one study, heart sounds from 100 patients were recorded, and the VoqX successfully identified issues in 50 patients with moderate or severe aortic stenosis. This trial will use computerized auscultation with the VoqX stethoscope, which listens to and analyzes heart sounds instantly, employing advanced technology to improve heart problem detection. Although still under testing, early results suggest it might perform similarly to well-known methods like echocardiograms. ^{2 3 6 7 8}

Who Is on the Research Team?

Rajiv Gulati, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults who need routine heart checks using echocardiography or cardiac catheterization. It's suitable for those with normal heart sounds, aortic stenosis, or mitral regurgitation. People with unstable heart/lung conditions or multiple valve diseases cannot participate.

Inclusion Criteria

I am scheduled for a heart ultrasound or a heart catheter test for health reasons.

My heart sounds are normal, or I have aortic stenosis or mitral regurgitation.

Exclusion Criteria

I have more than one type of heart valve disease.

I have stable heart and lung conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Baseline testing using the ©CompuSteth device to auscultate and record heart sounds at the bedside

Less than 10 minutes

1 visit (in-person)

Training Phase

Training the ©VoqX device with results from echocardiograms and cardiac catheterization procedures to identify cardiac pathologies

Duration not specified

Testing Phase

Testing the ©VoqX device's ability to screen and grade cardiac pathologies in subsequent participants

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ©CompuSteth stethoscope
• ©VoqX stethoscope

Trial Overview The study tests the ©VoqX stethoscope that records heart sounds and uses artificial intelligence to detect abnormalities, comparing its results to standard echocardiograms and cardiac catheterizations.

How Is the Trial Designed?

Group I: Computerized Auscultation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Participation in heart failure (HF) performance improvement registries, such as ADHERE and OPTIMIZE-HF, has led to significant enhancements in the use of guideline-recommended therapies for HF, improving patient care in both hospital and outpatient settings.

These registries have not only improved adherence to quality measures but have also resulted in better clinical outcomes for patients with HF, helping to reduce disparities in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving quality of care and outcomes for heart failure. -Role of registries-. Fonarow, GC.[2022]

Citations

1. amjmed.com amjmed.com/article/S0002-9343(22)00389-8/fulltext

Artificial Intelligence-Based Stethoscope for the Diagnosis ... The artificial intelligence-based stethoscope can be used for wide screening of patients for the presence of significant aortic stenosis.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002934322003898

Artificial Intelligence-Based Stethoscope for the Diagnosis ... In the first stage, using the VoqX, we recorded heart sounds from 100 patients referred for echocardiography (derivation group), 50 with moderate or severe AS ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04960280/a-study-to-evaluate-a-computerized-stethoscope-called-cvoqx-to-diagnose-heart-disease

A Study to Evaluate a Computerized Stethoscope Called ... The purpose of this study is to determine whether recording heart sounds with an acoustic stethoscope, combined with artificial intelligence ...

4. withpower.com withpower.com/trial/phase-aortic-valve-stenosis-9-2021-c2c1c

Computerized Stethoscope for Heart Disease The CompuSteth and VoqX stethoscopes are unique because they integrate electronic hardware and software to enhance the quality of heart sound detection, ...

5. binasss.sa.cr binasss.sa.cr/set22/11.pdf

Artificial Intelligence-Based Stethoscope for the Diagnosis ... Real-time heart sounds recordings were performed in the sitting position using an electronic stethoscope (VoqX, Sanolla). For each patient, 5 auscultation ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35640698/

Artificial Intelligence-Based Stethoscope for the Diagnosis ... In the first stage, using the VoqX, we recorded heart sounds from 100 patients referred for echocardiography (derivation group), 50 with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11633525/

Advances in Wearable Stethoscope Technology This review highlights the potential of wearable electronic stethoscopes to transform cardiovascular health management by enabling early diagnosis and self- ...

8. acc.org acc.org/latest-in-cardiology/journal-scans/2025/08/19/13/42/ai-based-stethoscopes

AI-Based Stethoscopes Can Accurately, Automatically ... Artificial intelligence (AI)-based stethoscopes can accurately diagnose left-sided valvular heart disease (VHD), according to original research ...