Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope
ConditionPulmonary Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEko Devices, Inc.
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Patients, ages >18 years, referred for complete 2-dimensional echocardiography or right heart catheterization will be screened for inclusion.
Disqualifiers
Patients undergoing limited echocardiography
Intubated patients
Trial population
Patients will be enrolled from Miriam and Rhode Island Hospital and Cardiovascular Institute outpatient locations where echocardiography or right heart catheterizations are performed. Approximately 40% of the patients enrolled will have a confirmed diagnosis of pulmonary hypertension.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Use of Eko DUO stethoscope (paired ECG/PCG)
DeviceAuscultation of heart sounds using electronic stethoscope
Treatment groups
2,420 Participants
are divided into 2 treatment groupsGroup A: Echocardiography ground-truth1 intervention
Group B: Right heart catheterization ground-truth1 intervention
Trial outcomes
Primary outcomes
1
Build a database of matched ECG/PCG recordings labeled against RHCs and echocardiograms
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)
Time frame
Up to 2 years to complete database2
Develop and clinically test a deep learning algorithm that can detect PH and stratify its severity
Deliver an algorithm that detects PH with a sensitivity and specificity of ≥ 0.7
Time frame
Up to 3 years to complete algorithm developmentSponsors and contacts
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Source ClinicalTrials.gov