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

December 18, 2025 updated by: Johannes Michael Altstidl, Friedrich-Alexander-Universität Erlangen-Nürnberg
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Deparment of Medicine 2 - Cardiology and Angiology, Friedrich-Alexander-Universität Erlangen-Nürnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

No relevant heart valve disease or severe aortic stenosis with no other relevant heart valve disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Severe Aortic Stenosis
Diagnostic test: Auscultation
Auscultation at five auscultation points using a digital stethoscope and a smartphone
No Relevant Heart Valve Disease
Diagnostic test: Auscultation
Auscultation at five auscultation points using a digital stethoscope and a smartphone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Algorithm Performance
Time Frame: Baseline
Performance of algorithmic diagnosis measured by accuracy, sensitivity, specificity, and positive predictive value
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison with Digital Stethoscope
Time Frame: Baseline
Comparison of algorithm performance using smartphone recordings with algorithm performance using digital stethoscope recordings
Baseline
Comparison of Auscultation Points
Time Frame: Baseline
Comparison of algorithm performance using different sets of auscultation points
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Friedrich-Alexander-Universität Erlangen-Nürnberg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Erlangen-Nürnberg Medical School
University Hospital Erlangen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 22, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-39-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Recordings and metadata are published

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

Dietary Supplements

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