Recruiting

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

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.

ClinicalTrials.gov IDNCT05873387

PhaseNot Applicable

Enrollment2420

SponsorEko Devices, Inc.

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Pulmonary Hypertension

About this study

Interventions

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

Primary outcomes

Build a database of matched ECG/PCG recordings labeled against RHCs and echocardiograms (Up to 2 years to complete database)
Develop and clinically test a deep learning algorithm that can detect PH and stratify its severity (Up to 3 years to complete algorithm development)

Eligibility information

Inclusion Criteria: * Patients, ages \>18 years, referred for complete 2-dimensional echocardiography or right heart catheterization will be screened for inclusion. Exclusion Criteria: * Patients undergoing limited echocardiography * Intubated patients

Study locations

Rhode Island Hospital, Providence, Rhode Island 02903 United States
The Miriam Hospital, Providence, Rhode Island 02906 United States
Providence VA Medical Center, Providence, Rhode Island 02908 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.