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OpenTrials
Completed

NCT Number: NCT03600051

Automated Phonocardiography Analysis in Adults

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with a heart defect verified by echocardiography

Treatment and study plan

Automated Heart Murmur Detection AI

Device

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.

Primary outcomes

  1. Sensitivity for pathological heart murmur detection

    Time frame: 2 months

    Ability to detect a pathological heart murmur in digital heart sound recordings obtained from an elderly population with heart valve disease.

Sponsors and collaborators

Lead sponsor

CSD Labs GmbH

Other

Registry information

Official study title

Phonokardiographie Bei Erwachsenen

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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