Deparment of Medicine 2 - Cardiology and Angiology, Friedrich-Alexander-Universität Erlangen-Nürnberg
Erlangen, 91054, Germany
NCT Number: NCT06404437
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Erlangen, 91054, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Auscultation at five auscultation points using a digital stethoscope and a smartphone
Time frame: Baseline
Performance of algorithmic diagnosis measured by accuracy, sensitivity, specificity, and positive predictive value
Time frame: Baseline
Comparison of algorithm performance using smartphone recordings with algorithm performance using digital stethoscope recordings
Time frame: Baseline
Comparison of algorithm performance using different sets of auscultation points
Friedrich-Alexander-Universität Erlangen-Nürnberg
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT05758909
Aortic Valve Disease, Aortic Valve Stenosis
A Coruña, Spain
View Trial DetailsNCT05454150
Aortic Valve Disease, Aortic Valve Stenosis
Annecy, France
View Trial DetailsNCT03666741
Aortic Valve Disease, Aortic Valve Stenosis
Sankt Pölten, Austria
View Trial DetailsNCT06449469
Aortic Valve Disease, Aortic Valve Stenosis
Aarhus, Denmark
View Trial Details