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NCT05080504 · ClinicalTrials.gov registry record

Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)

A clinical trial, sponsored by Eko Devices.

Completed
Registry status
17
Enrollment target

NCT05080504: Completed study, sponsored by Eko Devices.

NCT05080504 is a clinical trial that has completed, run by Eko Devices. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05080504 has completed, sponsored by Eko Devices.

COMPLETED
Registry status
17 participants
Enrollment target

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.

Primary Outcome

The primary objective of this proof of concept study is to demonstrate whether Eko data scientists can create an artificial intelligence machine learning (AI/ML) model of pulmonary artery (PA) pressures by analyzing sound and electrical (ECG) signals of heart activity captured by the non-invasive, FDA-cleared, Eko DUO electronic stethoscope.

Interventions

  • DEVICE Eko DUO

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2021-02-01
Est. Completion 2023-05-01
Eko Devices

16 total trials

What the finished NCT05080504 record still lists

NCT05080504 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Eko DUO is the first listed.

NCT05080504 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05080504 about?

NCT05080504 is a clinical study titled "Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)". 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 regime...

What is the current status of trial NCT05080504?

This trial is currently completed. The enrollment target is 17 participants. The study started on 2021-02-01. Estimated completion is 2023-05-01.

What interventions are being tested in trial NCT05080504?

The interventions under investigation include: Eko DUO (DEVICE).

Who is sponsoring clinical trial NCT05080504?

This trial is sponsored by Eko Devices, which has 16 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05080504, the US trial registry maintained by the National Library of Medicine. NCT05080504 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.