<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04404452</url>
  </required_header>
  <id_info>
    <org_study_id>2020.2</org_study_id>
    <nct_id>NCT04404452</nct_id>
  </id_info>
  <brief_title>Heart Failure Monitoring With Eko Electronic Stethoscopes</brief_title>
  <acronym>HOME0</acronym>
  <official_title>Heart Failure Monitoring With Eko Electronic Stethoscopes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eko Devices, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eko Devices, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proof-of-concept study will evaluate the feasibility of the Eko DUO to measure signals&#xD;
      relevant to heart failure (HF) decompensation, as well as the feasibility to develop an&#xD;
      algorithm to model hemodynamic filling pressures in HF patients under active decompensation&#xD;
      in a cardiac intensive care unit (CICU) or coronary care unit (CCU). To also assess the&#xD;
      performance of the Eko CORE to detect signals of an HF event, this study will also take heart&#xD;
      and lung sound measurements with the Eko CORE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart failure (HF) affects an estimated 6.2 million Americans over the age of 20 and has a&#xD;
      high cost burden worldwide. Many health plans, including CMS, have focused on interventions&#xD;
      that monitor patients for early detection of HF decompensation. Earlier interventions can&#xD;
      help care teams prevent avoidable hospitalizations.&#xD;
&#xD;
      Health systems have developed outpatient at-home monitoring solutions to predict and prevent&#xD;
      HF readmissions with mixed results. Despite equivocal results, telephone monitoring with&#xD;
      vital sign and weight scale monitors are the de facto standard for outpatient HF remote&#xD;
      monitoring. Invasive hemodynamic sensors have enabled HF care teams to better predict and&#xD;
      prevent HF decompensation events and thus rehospitalizations based on fluid status&#xD;
      assessment. Unfortunately, these solutions are invasive, costly, typically indicated for late&#xD;
      stage heart failure, and have limited availability due to equivocal cost-effectiveness&#xD;
      projections.&#xD;
&#xD;
      More recently, researchers have investigated non-invasive sensors that may correlate with&#xD;
      fluid status in HF patients. A study in Taiwan demonstrated that outpatient therapy guided by&#xD;
      an inpatient device with ECG and sound sensors reduced post-discharge HF utilization by 31%&#xD;
      when compared to a control group using symptoms to guide therapy. The LINK-HF study&#xD;
      demonstrated that a wearable patch with ECG and sound sensors could predict HF readmissions&#xD;
      with sensitivity of 76% to 88%, specificity of 85%, and a median lead time of 6.5 days.&#xD;
      Despite promising results, these devices have significant disadvantages. The inpatient device&#xD;
      used in the Taiwanese study was not able to be adapted into a portable form factor for&#xD;
      outpatient use, which would make it a poor candidate for at-home remote monitoring.&#xD;
      Conventional wearable devices also face usability challenges; they can be rigid,&#xD;
      uncomfortable, and highly visible, which can interfere with patient functional living and&#xD;
      decrease monitoring compliance.&#xD;
&#xD;
      There is an unmet clinical need for a non-invasive, affordable device that can estimate a HF&#xD;
      patient's hemodynamic fluid status and potentially guide a remote care team to decrease risk&#xD;
      for readmission from the comfort of the patient's home.&#xD;
&#xD;
      Eko has developed the DUO, an FDA-approved portable, hand-held, connected medical device with&#xD;
      ECG and sound sensors. Data from this device can be wirelessly streamed to a mobile phone or&#xD;
      tablet, which is transmitted to a HIPAA-compliant internet cloud infrastructure. This data&#xD;
      can then be analyzed by algorithms to detect disease states. Because patients in active HF&#xD;
      decompensation are known to have an audible third heart sound, characteristic ECG findings,&#xD;
      and adverse time interval durations between sound and ECG signals, the Eko DUO device may be&#xD;
      uniquely positioned to detect these types of changing signals, and predict if patients are&#xD;
      at-risk for a HF event, well in advance of the event itself.&#xD;
&#xD;
      Eko has also developed the Eko CORE, an FDA-approved electronic stethoscope with sound&#xD;
      sensors only. The CORE has otherwise identical functionality to the DUO in regard to data&#xD;
      streaming and transmission. The Eko CORE may be able to detect an audible third heart sound&#xD;
      as well, and therefore has the potential to aid clinicians in predicting future HF events. In&#xD;
      addition, because heart failure and fluid overload are reflected in the lungs as crackles&#xD;
      (and occasionally effusions), the lung examination is and has always been a cornerstone of&#xD;
      the overall physical examination of the patient in decompensated HF. By using the CORE to&#xD;
      capture lung sounds in patients with decompensated HF, and comparing not only the presence or&#xD;
      absence of crackles, but also how they change in correlation with the patient's response to&#xD;
      treatment, we will be able to explore the utility of the Eko CORE in helping treat these&#xD;
      patients.&#xD;
&#xD;
      This will be a proof-of-concept study to evaluate the feasibility of the Eko DUO to measure&#xD;
      signals relevant to HF decompensation, as well as the feasibility to develop an algorithm to&#xD;
      model hemodynamic filling pressures in HF patients under active decompensation in a cardiac&#xD;
      intensive care unit (CICU) or coronary care unit (CCU). To also assess the performance of the&#xD;
      Eko CORE to detect signals of an HF event, this study will also take heart and lung sound&#xD;
      measurements with the Eko CORE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Data not useful&#xD;
  </why_stopped>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Actual">December 14, 2020</completion_date>
  <primary_completion_date type="Actual">December 14, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of use of Eko DUO by protocol compliance</measure>
    <time_frame>Within two minutes of device use</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of use of Eko CORE</measure>
    <time_frame>Within two minutes of device use</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra-Subject Reproducibility of Normalized EMAT</measure>
    <time_frame>Within two minutes of device use</time_frame>
    <description>Assess intra-subject reproducibility of derived variables of interest, such as normalized EMAT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-Subject Reproducibility of HRV</measure>
    <time_frame>Within two minutes of device use</time_frame>
    <description>Assess intra-subject reproducibility of derived variables of interest, such as HRV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-Subject Reproducibility of S3 Heart Sound</measure>
    <time_frame>Within two minutes of device use</time_frame>
    <description>Assess intra-subject reproducibility of derived variables of interest, such as S3 heart sound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Algorithm Model Development of Hemodynamic Status based on time since invasive right heart catheter insertion</measure>
    <time_frame>Within two minutes of device use</time_frame>
    <description>Develop a model composed of derived variables that correlates with fluid hemodynamic status between the time a patient's invasive right heart catheter is inserted for ADHF treatment, until the time the patient's right heart catheter is removed.</description>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Heart Failure</condition>
  <condition>Crackles</condition>
  <condition>Heart Failure With Preserved Ejection Fraction</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Use of Eko CORE and Eko DUO electronic stethoscopes</intervention_name>
    <description>Auscultation of heart and lung sounds using electronic stethoscopes</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have recently been admitted to the CCU with a diagnosis of ADHF will be&#xD;
        recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults aged 18 years and older&#xD;
&#xD;
          2. Patient or patient's legal healthcare proxy consents to participation&#xD;
&#xD;
          3. Admitted to an CCU with a diagnosis of acute decompensated heart failure&#xD;
&#xD;
          4. Presence of indwelling right heart catheter&#xD;
&#xD;
          5. Receiving at least once daily hemodynamic measurements&#xD;
&#xD;
          6. Willing to have heart and lung sounds recorded with two different electronic&#xD;
             stethoscopes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient or proxy is unwilling or unable to give written informed consent&#xD;
&#xD;
          2. Patient is enrolled in another study that may interfere with the observations from&#xD;
             this study&#xD;
&#xD;
          3. Acute pericarditis&#xD;
&#xD;
          4. Healing chest wall wounds, such as in post-sternotomy patients&#xD;
&#xD;
          5. Pacemaker (single ventricle or biventricular) with active pacing&#xD;
&#xD;
          6. Mechanical ventricular support (such as ECMO, LVAD, RVAD, BiVAD, Impella, intra-aortic&#xD;
             balloon pumps)&#xD;
&#xD;
          7. Acute heart failure secondary to: a. Severe stenotic or regurgitant valvular disease;&#xD;
             b. Acute myocardial infarction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>MedStar Cardiovascular Network</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>March 4, 2021</last_update_submitted>
  <last_update_submitted_qc>March 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Machine learning</keyword>
  <keyword>Remote monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04404452
org study id: 2020.2
nct id: NCT04404452
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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 patients for early detection of HF decompensation. Earlier interventions can
      help care teams prevent avoidable hospitalizations.

      Health systems have developed outpatient at-home monitoring solutions to predict and prevent
      HF readmissions with mixed results. Despite equivocal results, telephone monitoring with
      vital sign and weight scale monitors are the de facto standard for outpatient HF remote
      monitoring. Invasive hemodynamic sensors have enabled HF care teams to better predict and
      prevent HF decompensation events and thus rehospitalizations based on fluid status
      assessment. Unfortunately, these solutions are invasive, costly, typically indicated for late
      stage heart failure, and have limited availability due to equivocal cost-effectiveness
      projections.

      More recently, researchers have investigated non-invasive sensors that may correlate with
      fluid status in HF patients. A study in Taiwan demonstrated that outpatient therapy guided by
      an inpatient device with ECG and sound sensors reduced post-discharge HF utilization by 31%
      when compared to a control group using symptoms to guide therapy. The LINK-HF study
      demonstrated that a wearable patch with ECG and sound sensors could predict HF readmissions
      with sensitivity of 76% to 88%, specificity of 85%, and a median lead time of 6.5 days.
      Despite promising results, these devices have significant disadvantages. The inpatient device
      used in the Taiwanese study was not able to be adapted into a portable form factor for
      outpatient use, which would make it a poor candidate for at-home remote monitoring.
      Conventional wearable devices also face usability challenges; they can be rigid,
      uncomfortable, and highly visible, which can interfere with patient functional living and
      decrease monitoring compliance.

      There is an unmet clinical need for a non-invasive, affordable device that can estimate a HF
      patient's hemodynamic fluid status and potentially guide a remote care team to decrease risk
      for readmission from the comfort of the patient's home.

      Eko has developed the DUO, an FDA-approved portable, hand-held, connected medical device with
      ECG and sound sensors. Data from this device can be wirelessly streamed to a mobile phone or
      tablet, which is transmitted to a HIPAA-compliant internet cloud infrastructure. This data
      can then be analyzed by algorithms to detect disease states. Because patients in active HF
      decompensation are known to have an audible third heart sound, characteristic ECG findings,
      and adverse time interval durations between sound and ECG signals, the Eko DUO device may be
      uniquely positioned to detect these types of changing signals, and predict if patients are
      at-risk for a HF event, well in advance of the event itself.

      Eko has also developed the Eko CORE, an FDA-approved electronic stethoscope with sound
      sensors only. The CORE has otherwise identical functionality to the DUO in regard to data
      streaming and transmission. The Eko CORE may be able to detect an audible third heart sound
      as well, and therefore has the potential to aid clinicians in predicting future HF events. In
      addition, because heart failure and fluid overload are reflected in the lungs as crackles
      (and occasionally effusions), the lung examination is and has always been a cornerstone of
      the overall physical examination of the patient in decompensated HF. By using the CORE to
      capture lung sounds in patients with decompensated HF, and comparing not only the presence or
      absence of crackles, but also how they change in correlation with the patient's response to
      treatment, we will be able to explore the utility of the Eko CORE in helping treat these
      patients.

      This will be a proof-of-concept study to evaluate the feasibility of the Eko DUO to measure
      signals relevant to 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.
observational model: Case-Only
time perspective: Prospective
measure: Feasibility of use of Eko DUO by protocol compliance
time frame: Within two minutes of device use
description: 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.
measure: Feasibility of use of Eko CORE
time frame: Within two minutes of device use
description: 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.
measure: Intra-Subject Reproducibility of Normalized EMAT
time frame: Within two minutes of device use
description: Assess intra-subject reproducibility of derived variables of interest, such as normalized EMAT.
measure: Intra-Subject Reproducibility of HRV
time frame: Within two minutes of device use
description: Assess intra-subject reproducibility of derived variables of interest, such as HRV
measure: Intra-Subject Reproducibility of S3 Heart Sound
time frame: Within two minutes of device use
description: Assess intra-subject reproducibility of derived variables of interest, such as S3 heart sound
measure: Algorithm Model Development of Hemodynamic Status based on time since invasive right heart catheter insertion
time frame: Within two minutes of device use
description: Develop a model composed of derived variables that correlates with fluid hemodynamic status between the time a patient's invasive right heart catheter is inserted for ADHF treatment, until the time the patient's right heart catheter is removed.
intervention type: Device
intervention name: Use of Eko CORE and Eko DUO electronic stethoscopes
description: Auscultation of heart and lung sounds using electronic stethoscopes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure