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Enrolling by invitation NCT07376785

Can Smartphones Listen to Your Heart? A Performance Study on Detecting Inborn Heart Diseases in Your Heart Sounds

Observational Congenital Heart Disease (CHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computer algorithms.
Who it may be relevant to
Registry conditions: Congenital Heart Disease (CHD). Basic parameters: from 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Smartphone-Based Use of Phonocardiography for Detection of Congenital Heart Disease: Diagnostic Performance Study

Overview

This observational study aims to assess the performance of the software called ausculto™. ausculto™ is a collection of computer algorithms that intend to analyse heart sounds recorded from the built-in microphone of a smartphone for abnormal sounds. Participants will have their heart sounds recorded during their normal attendance at the hospitals after consenting to participate in this study. Researchers will manually annotate the recorded heart sounds to create a database for use in future training and testing of artificial intelligence (AI) intended for medical uses.

Interventions

  • Diagnostic test Computer algorithms
    Collection of lightweight computer algorithms called ausculto™ that is designed to perform real-time heart sound analysis to detect heart murmur.

Primary outcome measures

  • Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings [Time frame: Day 0]
Secondary outcome measures (2)
  • Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings [Time frame: Day 0]
  • Number of Adverse Events Reported by Participants or Child Participants' Parent/Legal Guardian During and at the End of Heart Sound Recording That are Determined to be Caused by This Study [Time frame: Day 0]

Eligibility criteria

Inclusion criteria

  • Age: ≥ 6 years
  • Have undergone echocardiography within 3 years at their normal non-research hospital attendance

Exclusion criteria

  • Implanted active medical devices in the torso, such as pacemakers and defibrillators
  • Have purely non-congenital valvular heart disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Hong Kong · 2 centers
  • Queen Mary Hospital — Hong Kong
  • Hong Kong Children's Hospital — Kowloon Bay

Identifiers

NCT: NCT07376785 · AUSC-CHD · UW 25-328

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗