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Automated Algorithm Based Analysis of Phonocardiograms of Newborns

NCT02105480 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2018-07-17

No results posted yet for this study

Summary

The purpose of this double-blind pivotal clinical utility study is to determine on a large patient population whether heart murmurs can be reliably detected with high sensitivity and specificity using a locked, automated algorithm-based phonocardiogram analysis (also referred to as computer aided auscultation (CAA)).

Each patient is auscultated and diagnosed independently by a medical specialist. Additionally, for each patient, an echocardiogram is performed as the gold-standard for determining heart pathologies. The CAA results are compared to the findings of the medical professionals as well as to the echocardiogram findings.

Hypothesis: The specific (locked) CAA algorithms used in this study are able to automatically diagnose pathological heart murmurs in premature babies and newborns with at least the same accuracy as experienced medical specialists.

Conditions

  • Heart Murmurs
  • Mitral Valve Prolapse
  • Systolic Murmurs

Interventions

DEVICE

Computer aided auscultation (CAA)

Sponsors & Collaborators

  • CSD Labs GmbH

    lead OTHER

Principal Investigators

  • Gerhard Pichler, MD · Medical University of Graz

Eligibility

Min Age
1 Minute
Max Age
5 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-01-25
Completion
2017-01-18

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02105480 on ClinicalTrials.gov