CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
Eko DUOdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05080504
NCT05080504N/ACompleted
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Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)

Eko Devices, Inc.·observational·Posted Oct 15, 2021·Updated Feb 25, 2025

In Brief

An observational study evaluating Eko DUO for Heart Failure. Completed, enrolled 17 participants across 2 sites.

Detailed Summary

This study will enroll heart failure (HF) patients who are under active management with an implanted pulmonary artery pressure sensor (CardioMEMS). Subjects will be provided an electronic stethoscope (the Eko DUO) to take at-home heart sound, lung sound, and ECG recordings in conjunction with regimented CardioMEMS measurements. These two datasets will be used to confirm whether an AI/ML model to track HF status can be developed.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
CollaboratorsColumbia University, Sentara Norfolk General Hospital

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 15, 2021
Enrollment StartFeb 1, 2021
Primary CompletionApr 1, 2023
Study CompletionMay 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.7 years ago

Interventions

Eko DUOdevice

Each subject will take an Eko DUO device home and take DUO recordings immediately before or after their prescribed CardioMEMS measurements. The DUO recordings will be taken at 3 predefined chest locations: the right upper sternal border, left upper sternal border, and right anterolateral. Each DUO recording lasts about 15 seconds. The total time per recording session is expected to be 2-4 minutes, which allows for time between recordings and any potential repeat recordings. Study participation will last for 90 days.