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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06404437
Enrollment
100
Registered
2024-05-08
Start date
2023-03-09
Completion date
2026-03-01
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

Machine Learning, Digital Health, Heart Valve Disease, Cardiology

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTAuscultation

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

Sponsors

University of Erlangen-Nürnberg Medical School
CollaboratorOTHER
University Hospital Erlangen
CollaboratorOTHER
Friedrich-Alexander-Universität Erlangen-Nürnberg
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Algorithm PerformanceBaselinePerformance of algorithmic diagnosis measured by accuracy, sensitivity, specificity, and positive predictive value

Secondary

MeasureTime frameDescription
Comparison with Digital StethoscopeBaselineComparison of algorithm performance using smartphone recordings with algorithm performance using digital stethoscope recordings
Comparison of Auscultation PointsBaselineComparison of algorithm performance using different sets of auscultation points

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026