Automated Phonocardiography Analysis in Adults

Aortic Stenosis Clinical Trial

Official title:

Phonokardiographie Bei Erwachsenen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600051
• Other study ID #: GRZ03 (PbE)
• Status: Completed
• Start date: December 10, 2015
• Est. completion date: January 31, 2017

Study information

• Verified date: July 2018
• Source: CSD Labs GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 31, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with a heart defect verified by echocardiography

Related Conditions & MeSH terms

• Aortic Insufficiency
• Aortic Stenosis
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Constriction, Pathologic
• Insufficiency, Pulmonary
• Insufficiency, Tricuspid
• Mitral Insufficiency
• Mitral Insufficiency and Aortic Stenosis
• Mitral Valve Insufficiency
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Austria	University Hospital	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
CSD Labs GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity for pathological heart murmur detection	Ability to detect a pathological heart murmur in digital heart sound recordings obtained from an elderly population with heart valve disease.	2 months