Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope

RecruitingOBSERVATIONAL
Enrollment

1,513

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

August 1, 2026

Study Completion Date

August 1, 2026

Conditions
Pulmnary Hypertension
Interventions
DIAGNOSTIC_TEST

Eko CORE 500 phonocardiogram (PCG) recording

Noninvasive acquisition of heart sound (phonocardiogram, PCG) recordings using the FDA (U.S. Food and Drug Administration)-cleared Eko CORE 500 digital stethoscope. At least four 15-second recordings are collected at standard auscultation sites (aortic, pulmonic, tricuspid, mitral). Recordings are used solely for investigational algorithm development and are not used for diagnostic or clinical decision-making.

DIAGNOSTIC_TEST

Eko CORE 500 three-lead electrocardiogram (ECG) recording

Noninvasive acquisition of three-lead electrocardiogram (ECG) signals using the FDA-cleared Eko CORE 500 digital stethoscope. Recordings are obtained simultaneously with PCG at auscultation sites. Data are used solely for investigational algorithm development and are not intended for diagnostic use.

Trial Locations (1)

90095

RECRUITING

University of California Los Angeles, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Eko Devices, Inc.

INDUSTRY

NCT07136623 - Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope | Biotech Hunter | Biotech Hunter