RECRUITING
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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 regimented CardioMEMS measurements. These two datasets will be used to confirm whether an AI/ML model to track HF status can be developed.
Conditions:
🦠 Heart Failure
🗓️ Study Start (Actual) 1 February 2021
🗓️ Primary Completion (Estimated) 1 April 2023
✅ Study Completion (Estimated) 1 May 2023
👥 Enrollment (Estimated) 50
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 New York, New York, United States
📍 Norfolk, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 September 2021
  • First Submitted that Met QC Criteria 14 October 2021
  • First Posted 15 October 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 November 2022
  • Last Update Posted 21 November 2022
  • Last Verified November 2022
I'm interested ...!!