Status:
TERMINATED
Heart Failure Monitoring With Eko Electronic Stethoscopes
Lead Sponsor:
Eko Devices, Inc.
Conditions:
Heart Failure
Crackles
Eligibility:
All Genders
18+ years
Brief Summary
This proof-of-concept study will evaluate the feasibility of the Eko DUO to measure signals relevant to heart failure (HF) decompensation, as well as the feasibility to develop an algorithm to model h...
Detailed Description
Heart failure (HF) affects an estimated 6.2 million Americans over the age of 20 and has a high cost burden worldwide. Many health plans, including CMS, have focused on interventions that monitor pati...
Eligibility Criteria
Inclusion
- Adults aged 18 years and older
- Patient or patient's legal healthcare proxy consents to participation
- Admitted to an CCU with a diagnosis of acute decompensated heart failure
- Presence of indwelling right heart catheter
- Receiving at least once daily hemodynamic measurements
- Willing to have heart and lung sounds recorded with two different electronic stethoscopes
Exclusion
- Patient or 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, such as in post-sternotomy patients
- Pacemaker (single ventricle or biventricular) with active pacing
- Mechanical ventricular support (such as ECMO, LVAD, RVAD, BiVAD, Impella, intra-aortic balloon pumps)
- Acute heart failure secondary to: a. Severe stenotic or regurgitant valvular disease; b. Acute myocardial infarction
Key Trial Info
Start Date :
July 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04404452
Start Date
July 6 2020
End Date
December 14 2020
Last Update
March 8 2021
Active Locations (1)
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1
MedStar Cardiovascular Network
Washington D.C., District of Columbia, United States, 20010