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Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)

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ClinicalTrials.gov Identifier: NCT05080504
Recruitment Status : Not yet recruiting
First Posted : October 15, 2021
Last Update Posted : October 28, 2021
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Eko Devices, Inc.

Brief 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.

Condition or disease Intervention/treatment
Heart Failure Device: Eko DUO

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Study Population
Subjects with implanted CardioMEMS who are actively managed through Columbia University Medical Center will be enrolled.
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.





Primary Outcome Measures :
  1. Correlation between AI/ML model output and the ground-truth of CardioMEMS PA pressure measurements. [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Composite of the incidence of poor-quality ECG or PCG data and tabulation of patient compliance with the data measurement schedule [ Time Frame: 6 months ]
    A secondary objective of the study is to assess the usability of the Eko DUO by patients at home

  2. Intra-subject reproducibility of measured variables [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be primarily recruited at Columbia University Medical Center (CUMC). Patients will be identified via the medical center's registry of patients who are actively managed with CardioMEMS. Alternatively, the center's schedule of CardioMEMS implantations will be monitored for potential subjects with newly implanted CardioMEMS.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05080504


Contacts
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Contact: Ben Verschoore, BS 443-545-6094 ben.verschoore@ekohealth.com

Sponsors and Collaborators
Eko Devices, Inc.
Columbia University
Investigators
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Principal Investigator: Nir Uriel, MD Columbia University
Principal Investigator: Gabriel Sayer, MD Columbia University
Publications:
Sehatbakhsh, Samineh, Stephanie Hakimian, Yash Jobanputra, Rosmy Jimmy, Robert Chait, Mark Showronski, Kaustubh Kale, and Steven Borzak. 2018. "Assessment of LV Systolic Function Using Cardiac Time Intervals with an Acoustic Array Approach." Journal of Cardiac Failure 24 (8): S38.
Sung, Shih-Hsien, Wen-Chung Yu, Hao-Min Cheng, Yu-Ping Chang, and Chen-Huan Chen. 2019. "USE OF ACOUSTIC CARDIOGRAPHY TO GUIDE OUTPATIENT THERAPY OF PATIENTS WITH ACUTE HEART FAILURE SYNDROME." Journal of the American College of Cardiology 63 (12 Supplement): A541.
"Trends in Hospital Readmissions and Mortality Rates - American College of Cardiology." N.d. American College of Cardiology. Accessed April 2, 2020. https://www.acc.org/latest-in-cardiology/journal-scans/2019/07/10/09/53/evaluation-of-30-day-hospital-readmission.
Hulley SB, Cummings SR, Browner WS, Grady D, Newman TB. Designing Clinical Research: An Epidemiologic Approach. 4th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2013. Appendix 6C, p79.

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Responsible Party: Eko Devices, Inc.
ClinicalTrials.gov Identifier: NCT05080504    
Other Study ID Numbers: AAAT7974(M00Y01)
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases