Recruiting

Phonocardiography

Sponsor:

Eko Devices, Inc.

Code:

NCT05873387

Conditions

Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Use of Eko DUO stethoscope (paired ECG/PCG)

Study Details

Brief 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.

Conditions

Pulmonary Hypertension

Study ID

NCT05873387

Start date

Jul 12, 2023

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

2420 participants

Anticipated

Interventions and Outcome Measures

Arms

Echocardiography ground-truth

Subjects with ECG/PCG recordings labeled against echocardiography

Right heart catheterization ground-truth

Subjects with ECG/PCG recordings labeled against right heart catheterization

Interventions

Use of Eko DUO stethoscope (paired ECG/PCG)

Auscultation of heart sounds using electronic stethoscope

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Spencer Kieu

714-623-6652spencer.kieu@ekohealth.com

Locations

Providence VA Medical Center

Recruiting

Providence, Rhode Island, United States, 02908

Contacts

Pamela Brewer, PhD, RN

401-273-71ooPamela.Brewer2@va.gov

More Information

Sponsor

Eko Devices, Inc.

Last update posted

Aug 24, 2026

Last verified

Jun, 2026

Keywords

  • digital stethoscopes
  • deep learning
  • auscultation
  • electrocardiogram

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eko Devices, Inc. on 2026-08-24.