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OpenTrials
Completed

NCT Number: NCT05325723

Evaluation of an Automated Smartphone-based Digital Auscultation Application for Detecting Abnormal Heart Sounds Using Deep Learning Techniques

This pilot study is to investigate the feasibility of obtaining medical grade audio phonocardiogram (PCG) recordings using a smartphone-based auscultation device in the first step. The ability to determine Valvular Heart Disease (VHD) (i.e., presence or absence of cardiac murmurs) using novel handheld CAA-devices shall be analyzed and first data on a smartphone-based auscultation in a hospital setting shall be collected. In further studies, the data provided from this study can be used to investigate the potential diagnostic use of such devices in the ambulatory and stationary care scenarios.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Division of Internal Medicine

Basel, 4031, Switzerland

About this study

Cardiac auscultation is considered to be highly subjective with substantial varying sensitivities and specificities in regard of the practitioners' expertise. Computer-assisted auscultation (CAA) aims to provide increased objectivity. CAA makes auscultation procedure less operator-dependent, approximate inter-examiner differences and may reduce uncertainties in the course of the examination. With the introduction of modern Machine Learning software libraries and ever-growing computational resources CAA has advanced significantly and is now able to classify heart sounds and murmurs into normal and abnormal, using complex spectro-temporal signal processing techniques and neural network pathways. CAA has simultaneously made the shift from the deployment on computers to consumer smartphones. A benefit of CAA can be expected from the smartphone alone in terms of cost, application range, the clinical validity of such algorithms should now be measured in this pilot study. This pilot study is to investigate the feasibility of obtaining medical grade audio phonocardiogram (PCG) recordings using a smartphone-based auscultation device in the first step. In further studies, the data provided from this study can be used to investigate the potential diagnostic use of such devices in the ambulatory and stationary care scenarios.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Older or equal than 18 years of age
  • Referred for an echocardiogram
  • Able to provide informed consent

Exclusion criteria

  • Confirmed arrythmia
  • Prior valvular intervention
  • Evidence of congenital heart disease

Treatment and study plan

Primary outcomes

  1. Determination of Valvular Heart Disease (VHD) (i.e., presence or absence of cardiac murmurs)

    Time frame: one time assessment at baseline (approx. 5 minutes)

    Ability to determine VHD (i.e., presence or absence of cardiac murmurs) using novel handheld CAA-devices is investigated by collection of data on a smartphone-based auscultation in a hospital setting.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Evaluation of an Automated Smartphone-based Digital Auscultation Application for Detecting Abnormal Heart Sounds Using Deep Learning Techniques - the Automated Valvular Heart Disease Assessment (AVDA) Pilot Study

Acronym: AVDA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2022
Registry last updated
Sep 14, 2023

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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