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NCT05873387Recruiting

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

Deep Learning for Algorithmic Detection of Pulmonary Hypertension Using a Combined Digital Stethoscope and Single-lead Electrocardiogram
Eko Devices, Inc.ClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Pulmonary Hypertension
Drug/Device/Intervention
Use of Eko DUO stethoscope (paired ECG/PCG)
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Eko Devices, Inc.
Location
Providence,Providence, United States of America
Timeline & enrollment
Phase
N/A
Start date
Jul 12, 2023
End date
Dec 01, 2025
Enrollment
2420 participants
Primary outcome

Build a database of matched ECG/PCG recordings labeled against RHCs and echocardiograms,Develop and clinically test a deep learning algorithm that can detect PH and stratify its severity

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.

ICD-10 classifications
Primary pulmonary hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationPulmonary heart disease, unspecifiedPulmonary valve disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05873387
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05873387 through Pure Global AI's free database. This phase not specified trial is sponsored by Eko Devices, Inc. and is currently Recruiting. The study focuses on Pulmonary Hypertension. Target enrollment is 2420 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.