Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)

Completed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT05080504

Run by

Eko Devices, Inc.

People needed

17

Starts

2021-02-01

Expected to finish

2023-05-01

Last updated by the study team

2025-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years and older
• Patient or healthcare proxy willing to give written informed consent to participate
• Presence of an implanted CardioMEMS device or imminent implantation of a CardioMEMS device
• Expressed willingness to take DUO recordings immediately before or after taking their CardioMEMS measurements, on the same schedule prescribed by their physician
• Functioning iOS or Android smartphone or tablet that can download and run the companion Eko application
• Access to WiFi or cellular data connection at home

You may not qualify if…

• Patient or healthcare proxy is unwilling or unable to give written informed consent
• Patient is enrolled in another study that may interfere with the observations from this study
• Acute pericarditis
• Healing chest wall wounds (e.g., sternotomy or thoracotomy)

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States
• Sentara Cardiovascular Research Institute — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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