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OpenTrials
Active, Not Recruiting

NCT Number: NCT06404437

Detection of Aortic Stenosis With Smartphone Auscultation Using Machine Learning (HEARTBEAT-Pilot)

Severe aortic stenosis, a common heart valve issue, is usually treated surgically or through intervention. Diagnosis typically occurs after symptoms appear, but research suggests already treating asymptomatic cases may help patients live longer. Current diagnostics using echocardiography are detailed but time-consuming, prompting the exploration of a smartphone application using built-in microphones and machine learning for quicker and more accessible screening.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Deparment of Medicine 2 - Cardiology and Angiology, Friedrich-Alexander-Universität Erlangen-Nürnberg

Erlangen, 91054, Germany

About this study

Severe aortic stenoses usually is treated either surgically or interventionally, making it the most frequently treated among heart valve diseases. Typically, severe aortic stenosis is diagnosed only after the onset of the first symptoms. However, initial studies suggest that treating asymptomatic aortic stenoses could also extend the lifespan of affected individuals. Therefore, a widely applicable and cost-effective diagnostic method would be desirable for screening.

The current gold standard for diagnosing aortic stenosis is echocardiography. It allows for detailed measurement and evaluation, assisting in detection and diagnostic assessment. However, it is time-consuming and therefore not readily applicable to a larger population. Alternatively, auscultation as an acoustic method is suitable, where typical noise changes due to turbulence in blood flow can be detected using a stethoscope.

Since stethoscopes are only conditionally accessible for self-use, both in terms of availability and usability, this study aims to investigate whether a mobile application based on artificial intelligence for common smartphones using built-in microphones can also be diagnostically used. For this purpose, microphone recordings at the typical five auscultation points of 50 patients with severe aortic stenosis and 50 patients without any relevant heart valve disease are recorded. A digital stethoscope (3M Deutschland GmbH, Germany) and echocardiography findings serve as references. Based on the data, a classification model will be developed in a first step, which can detect severe aortic stenoses in smartphone recordings using machine learning.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • No relevant heart valve disease or severe aortic stenosis with no other relevant heart valve disease in echocardiography no older than 3 months

Exclusion criteria

  • Previous surgerical or interventional therapy of a heart valve

Treatment and study plan

Auscultation

Diagnostic Test

Auscultation at five auscultation points using a digital stethoscope and a smartphone

Primary outcomes

  1. Algorithm Performance

    Time frame: Baseline

    Performance of algorithmic diagnosis measured by accuracy, sensitivity, specificity, and positive predictive value

Secondary outcomes

  1. Comparison with Digital Stethoscope

    Time frame: Baseline

    Comparison of algorithm performance using smartphone recordings with algorithm performance using digital stethoscope recordings

  2. Comparison of Auscultation Points

    Time frame: Baseline

    Comparison of algorithm performance using different sets of auscultation points

Sponsors and collaborators

Lead sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Other

Collaborators

  • University Hospital Erlangen
  • University of Erlangen-Nürnberg Medical School

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
May 8, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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