<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/NCT03751904</url>
  </required_header>
  <id_info>
    <org_study_id>SIG-0001</org_study_id>
    <nct_id>NCT03751904</nct_id>
  </id_info>
  <brief_title>Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™</brief_title>
  <official_title>Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Signature Medical, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Signature Medical, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac&#xD;
      pressures using heart sounds in patients with heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor is no longer pursuing the study.&#xD;
  </why_stopped>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Anticipated">March 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>Subjects will be assessed for adverse events through study completion, an average of 1 day</time_frame>
    <description>The safety of the Acousticare device will be assessed by reviewing adverse events in all patients enrolled in the study</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Heart Failure，Congestive</condition>
  <arm_group>
    <arm_group_label>AcoustiCare</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single Arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AcoustiCare</intervention_name>
    <description>Electronic stethoscope</description>
    <arm_group_label>AcoustiCare</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects between the ages of 18 - 80 years&#xD;
&#xD;
          2. Willing and able to sign informed consent form&#xD;
&#xD;
          3. Normal subjects without a history of heart disease who are recruited from the&#xD;
             surrounding community&#xD;
&#xD;
          4. Subjects with heart failure undergoing treatment in a hospital setting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hemodynamic instability (Systolic BP&gt;180 or &lt;90 and Diastolic BP&gt;90 and &lt;60)&#xD;
&#xD;
          2. Acute coronary syndrome&#xD;
&#xD;
          3. Prior heart transplant recipients&#xD;
&#xD;
          4. Subjects who are pacemaker dependent&#xD;
&#xD;
          5. Severe obesity (body mass index &gt; 40 kg/m2)&#xD;
&#xD;
          6. Subjects who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03751904
org study id: SIG-0001
nct id: NCT03751904
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac
      pressures using heart sounds in patients with heart failure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Incidence of Adverse Events
time frame: Subjects will be assessed for adverse events through study completion, an average of 1 day
description: The safety of the Acousticare device will be assessed by reviewing adverse events in all patients enrolled in the study
arm group label: AcoustiCare
arm group type: Other
description: Single Arm
intervention type: Device
intervention name: AcoustiCare
description: Electronic stethoscope
arm group label: AcoustiCare
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Heart Failure