Heart Failure Monitoring With Eko Electronic Stethoscopes

NCT04404452 | Terminated

• 1 other identifier: 2020.2
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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 hemodynamic filling pressures in HF patients under active decompensation in a cardiac intensive care unit (CICU) or coronary care unit (CCU). To also assess the performance of the Eko CORE to detect signals of an HF event, this study will also take heart and lung sound measurements with the Eko CORE.

Conditions

Heart Failure; Crackles; Heart Failure With Preserved Ejection Fraction

Keywords

Machine learning; Remote monitoring

Outcome Measures

Primary Outcomes (2)

• Feasibility of use of Eko DUO by protocol compliance

  Assess the feasibility of use of the Eko DUO, a non-invasive cutaneous device with simultaneous ECG and PCG recording, on ADHF patients in an CICU/CCU setting based on ease of protocol compliance.

  Within two minutes of device use

• Feasibility of use of Eko CORE

  Assess the feasibility of use of the Eko CORE, a non-invasive cutaneous device with PCG recording, on ADHF patients in an CICU/CCU setting based on ease of protocol compliance.

  Within two minutes of device use

Secondary Outcomes (4)

• Intra-Subject Reproducibility of Normalized EMAT

  Within two minutes of device use

• Intra-Subject Reproducibility of HRV

  Within two minutes of device use

• Intra-Subject Reproducibility of S3 Heart Sound

  Within two minutes of device use

• Algorithm Model Development of Hemodynamic Status based on time since invasive right heart catheter insertion

  Within two minutes of device use

Interventions

Use of Eko CORE and Eko DUO electronic stethoscopes DEVICE

Auscultation of heart and lung sounds using electronic stethoscopes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have recently been admitted to the CCU with a diagnosis of ADHF will be recruited.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eko Devices, Inc.: lead

Study Sites (1)

MedStar Cardiovascular Network

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Heart Failure; Respiratory Sounds

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 27, 2020
• Study Start: July 6, 2020
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

US (1)