Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)

NCT05080504 | Completed FDA Device

• 1 other identifier: 2022.1
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Correlation between AI/ML model output and the ground-truth of CardioMEMS PA pressure measurements.

  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.

  6 months

Secondary Outcomes (2)

• Composite of the incidence of poor-quality ECG or PCG data and tabulation of patient compliance with the data measurement schedule

  6 months

• Intra-subject reproducibility of measured variables

  6 months

Study Arms (1)

Study Population

Subjects with implanted CardioMEMS who are compliant with their measurements.

Device: Eko DUO

Interventions

Eko DUO DEVICE

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.

Study Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

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)

Sponsors & Collaborators

• Eko Devices, Inc.: lead
• Columbia University: collaborator
• Sentara Norfolk General Hospital: collaborator

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 22191, United States

Location

Related Publications (20)

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  PMID: 31776915 BACKGROUND

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  PMID: 27039130 BACKGROUND

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  PMID: 28982501 BACKGROUND

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  PMID: 20687083 BACKGROUND

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  PMID: 17883993 BACKGROUND

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  PMID: 28546776 BACKGROUND

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  PMID: 21444883 BACKGROUND

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  PMID: 17241326 BACKGROUND

• Schmier JK, Ong KL, Fonarow GC. Cost-Effectiveness of Remote Cardiac Monitoring With the CardioMEMS Heart Failure System. Clin Cardiol. 2017 Jul;40(7):430-436. doi: 10.1002/clc.22696. Epub 2017 Mar 8.

  PMID: 28272808 BACKGROUND

• 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.

  BACKGROUND

• Stehlik J, Schmalfuss C, Bozkurt B, Nativi-Nicolau J, Wohlfahrt P, Wegerich S, Rose K, Ray R, Schofield R, Deswal A, Sekaric J, Anand S, Richards D, Hanson H, Pipke M, Pham M. Continuous Wearable Monitoring Analytics Predict Heart Failure Hospitalization: The LINK-HF Multicenter Study. Circ Heart Fail. 2020 Mar;13(3):e006513. doi: 10.1161/CIRCHEARTFAILURE.119.006513. Epub 2020 Feb 25.

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• 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.

  BACKGROUND

• Toukhsati SR, Driscoll A, Hare DL. Patient Self-management in Chronic Heart Failure - Establishing Concordance Between Guidelines and Practice. Card Fail Rev. 2015 Oct;1(2):128-131. doi: 10.15420/cfr.2015.1.2.128.

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• "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.

  BACKGROUND

• Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.

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• Zohrabian A, Kapp JM, Simoes EJ. The economic case for US hospitals to revise their approach to heart failure readmission reduction. Ann Transl Med. 2018 Aug;6(15):298. doi: 10.21037/atm.2018.07.30.

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  BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Deepak Talreja, MD

  Sentara Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 15, 2021
• Study Start: February 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

US (2)