Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
90 participants
OBSERVATIONAL
2015-12-10
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Automated Algorithm Based Analysis of Phonocardiograms of Newborns
NCT02105480
Precision of AI-Based Cardiac Ultrasound for LVEF in the Elderly
NCT06478901
AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy
NCT07263204
AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography
NCT07144189
Prognostic Role of AI-Echo
NCT07009639
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CSD Labs GmbH
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rita Riedlbauer, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital
Graz, Styria, Austria
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GRZ03 (PbE)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.