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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment ©CompuSteth stethoscope, ©VoqX stethoscope for heart disease?

While there is no direct data on the effectiveness of the ©CompuSteth and ©VoqX stethoscopes, similar telehealth technologies have been shown to reduce hospital readmissions and improve quality of life for heart disease patients by allowing remote monitoring and better self-care. ^{1 2 3 4 5}

How does the CompuSteth and VoqX stethoscope treatment differ from other heart disease treatments?

The CompuSteth and VoqX stethoscopes are unique because they integrate electronic hardware and software to enhance the quality of heart sound detection, allowing for noise cancellation and high-quality sound interpretation. This makes them particularly useful for early diagnosis and remote cardiac examination, unlike traditional stethoscopes that rely solely on manual auscultation. ^{6 7 8 9 10}

Research Team

Rajiv Gulati, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Remote monitoring of heart failure patients. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Collaborative Quality Improvement Strategy in Secondary Prevention of Cardiovascular Disease in India: Findings from a Multi-Stakeholder, Qualitative Study using Consolidated Framework for Implementation Research (CFIR). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Telehome monitoring in patients with cardiac disease who are at high risk of readmission. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Development of a tele-stethoscope and its application in pediatric cardiology. [2007]

7. Iran pubmed.ncbi.nlm.nih.gov

A New Stethoscope Design with Unique Characteristics and Development in Medical Device. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Heart sounds: Past, present, and future from a technological and clinical perspective - a systematic review. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Automated detection of low ejection fraction from a one-lead electrocardiogram: application of an AI algorithm to an electrocardiogram-enabled Digital Stethoscope. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Stereophonic stethoscope with teaching attachment. [2019]