Valvular Heart DiseaseAVDANCT05325723
Evaluation of an Automated Smartphone-based Digital Auscultation Application for Detecting Abnormal Heart Sounds Using Deep Learning Techniques
An observational study of Valvular Heart Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Valvular Heart Disease
- How many people
- 102 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Aug 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited at the Department of Cardiology, University Hospital Basel. The scheduled appointment lists of patients for an echocardiography will be checked and eligible patients will be contacted by the study physician before presenting for their planned echocardiography appointment.
Who may be able to join
- Older or equal than 18 years of age
- Referred for an echocardiogram
- Able to provide informed consent
Who cannot join
- Confirmed arrythmia
- Prior valvular intervention
- Evidence of congenital heart disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Division of Internal Medicine
Basel, 4031
About this study
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
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.
Read the detailed 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.
- Conditions
- Valvular Heart Disease
- Keywords
- automated digital auscultation, deep learning technique, smartphone-based digital auscultation, Computer-assisted auscultation (CAA), artificial neural networks (ANN), heart sound (HS) identification, medical grade audio phonocardiogram (PCG)
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | 1. 30 second audio phonocardiogram (PCG) recordings at each of the five standard cardiac auscultatory positions using an Apple iPhone®. 2. the assessment of VHD by echocardiogram, as reported by the echocardiography laboratory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one time assessment at baseline (approx. 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start30 Aug 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, Prof. Dr. med., Principal investigator, University Hospital Basel, Division of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325723
- Sponsor's protocol ID
- 2021-02515; am21Eckstein
- Acronym
- AVDA
- Status last verified
- Sep 2023
- First submitted
- 5 Apr 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05325723
- Acronym / sponsor ID
- AVDA / 2021-02515; am21Eckstein
- Conditions
- Valvular Heart Disease
- Keywords
- automated digital auscultation, deep learning technique, smartphone-based digital auscultation, Computer-assisted auscultation (CAA), artificial neural networks (ANN), heart sound (HS) identification, medical grade audio phonocardiogram (PCG)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | –1. 30 second audio phonocardiogram (PCG) recordings at each of the five standard cardiac auscultatory positions using an Apple iPhone®. 2. the assessment of VHD by echocardiogram, as reported by the echocardiography laboratory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited at the Department of Cardiology, University Hospital Basel. The scheduled appointment lists of patients for an echocardiography will be checked and eligible patients will be contacted by the study physician before presenting for their planned echocardiography appointment.
Key inclusion criteria (3 listed)
- Older or equal than 18 years of age
- Referred for an echocardiogram
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Confirmed arrythmia
- Prior valvular intervention
- Evidence of congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Eckstein, Prof. Dr. med. principal investigator
University Hospital Basel, Division of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Valvular Heart Disease (VHD) (i.e., presence or absence of cardiac murmurs) (time frame: one time assessment at baseline (approx. 5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.