Trials / Completed
CompletedNCT03600051
Automated Phonocardiography Analysis in Adults
Phonokardiographie Bei Erwachsenen
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 90 (actual)
- Sponsor
- CSD Labs GmbH · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers in identifying pathological heart murmurs and may avoid unnecessary referrals to medical specialists. Objective: Assess the quality of the artificial intelligence (AI) algorithm that autonomously detects and classifies heart murmurs as either pathologic (AHA class I) or as no- or innocent (AHA class III). Hypothesis: The algorithm used in this study is able to analyze and identify pathologic heart murmurs (AHA class I) in an adult population with valve defects with a similar sensitivity compared to medical specialist. Methods: Each patient is auscultated and diagnosed independently by a medical specialist by means of standard auscultation. Auscultation findings are verified via gold-standard echocardiogram diagnosis. For each patient, a phonocardiogram (PCG) - a digital recording of the heart sounds - is acquired. The recordings are later analyzed using the AI algorithm. The algorithm results are compared to the findings of the medical professionals as well as to the echocardiogram findings.
Conditions
- Aortic Insufficiency
- Aortic Stenosis
- Mitral Insufficiency
- Mitral Insufficiency and Aortic Stenosis
- Tricuspid Regurgitation
- Insufficiency, Pulmonary
- Insufficiency, Tricuspid
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Automated Heart Murmur Detection AI | Automated AI algorithm-based analysis of digital heart sound recordings to detect pathological heart murmurs. Heart sound recordings were fully blinded before undergoing one-time automated analysis. Algorithm results for each recording included: AHA classification (I "pathologic" versus III "innocent/no murmur"), murmur timing, murmur grade, heart rate and S1/S2 identification. |
Timeline
- Start date
- 2015-12-10
- Primary completion
- 2017-01-18
- Completion
- 2017-01-31
- First posted
- 2018-07-26
- Last updated
- 2018-07-26
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT03600051. Inclusion in this directory is not an endorsement.