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

Valvular Heart Disease Clinical Trial

— AVDA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05325723
• Other study ID #: 2021-02515; am21Eckstein
• Status: Completed
• Start date: August 30, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Division of Internal Medicine	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of Valvular Heart Disease (VHD) (i.e., presence or absence of cardiac murmurs)	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.	one time assessment at baseline (approx. 5 minutes)