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Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)

NCT05080504 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2025-02-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Eko DUO

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.

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

  • Sentara Norfolk General Hospital

    collaborator OTHER

  • Eko Devices, Inc.

    lead INDUSTRY

Principal Investigators

  • Deepak Talreja, MD · Sentara Healthcare

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-04-01
Completion
2023-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05080504 on ClinicalTrials.gov