Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope

Condition(s) studied

Investigational drug(s) / intervention(s)

Use of Eko DUO stethoscope (paired ECG/PCG): Auscultation of heart sounds using electronic stethoscope

Study summary

The major goal of the study is to determine whether phonocardiography (using the Eko DUO stethoscope which can capture a three lead ECG reading) can present features that relate to the presence of PH diagnosed by echocardiography or right heart catheterization (RHC), and therefore have a potential to assist the provider to suspect PH.

Eligibility

Primary outcome measure(s)

• Build a database of matched ECG/PCG recordings labeled against RHCs and echocardiograms — Up to 2 years to complete database
  Create a training/validation dataset composed of ECG/PCG recordings by enrolling at least 2200 subjects undergoing echocardiography and at least 220 subjects who have undergone right heart catheterization (RHC)
• Develop and clinically test a deep learning algorithm that can detect PH and stratify its severity — Up to 3 years to complete algorithm development
  Deliver an algorithm that detects PH with a sensitivity and specificity of ≥ 0.7

Trial sites (3)

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