Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG

RecruitingOBSERVATIONAL
Enrollment

3,850

Participants

Timeline

Start Date

June 15, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Hypertension, PulmonaryHeart Failure With Reduced Ejection Fraction
Interventions
DEVICE

Eko CORE 500 Digital Stethoscope

The FDA-cleared Eko CORE 500 digital stethoscope is used to collect phonocardiogram (PCG) and three-lead ECG recordings from participants. This observational study uses these recordings to develop and validate artificial intelligence algorithms to detect pulmonary hypertension and low left ventricular ejection fraction. No modifications to the device or device functionality are being tested.

Trial Locations (3)

62269

RECRUITING

Prairie Cardiovascular, O'Fallon

62769

RECRUITING

Prairie Education & Research Cooperative, Springfield

RECRUITING

St Johns Hospital, Springfield, Springfield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Eko Devices, Inc.

INDUSTRY

NCT07087613 - Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG | Biotech Hunter | Biotech Hunter