Automated Phonocardiography Analysis in Adults

NCT ID: NCT03600051

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-10

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Insufficiency Aortic Stenosis Mitral Insufficiency Mitral Insufficiency and Aortic Stenosis Tricuspid Regurgitation Insufficiency, Pulmonary Insufficiency, Tricuspid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults with a heart defect verified by echocardiography
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSD Labs GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rita Riedlbauer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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University Hospital

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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GRZ03 (PbE)

Identifier Type: -

Identifier Source: org_study_id

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