<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/NCT03228381</url>
  </required_header>
  <id_info>
    <org_study_id>BOSS CT005</org_study_id>
    <nct_id>NCT03228381</nct_id>
  </id_info>
  <brief_title>The BOSS Study: An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)</brief_title>
  <acronym>BOSS</acronym>
  <official_title>An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mardil Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mardil Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the BOSS Study is to assess acute anatomical and geometric annular and&#xD;
      ventricular changes that occur when strategically positioned an external inflatable chambers&#xD;
      are applied to the outside of the heart.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mardil Medical is developing an investigational device for functional mitral regurgitation&#xD;
      intended to provide ventricular support with adjustable inflatable chambers to reduce annular&#xD;
      dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation.&#xD;
      In doing so, Mardil Medical is interested in exploring the anatomical and geometric annular&#xD;
      and ventricular changes that occur when strategically positioned external inflatable chambers&#xD;
      are applied to the outside of the heart. Favorable benefits of circumferential reduction in&#xD;
      ventricular wall stress favoring left ventricular (LV) remodeling and acute reshaping of LV&#xD;
      segments subtending the deformed mitral valve apparatus needs to be better understood. Mardil&#xD;
      Medical is pursuing this study as an initial phase in the Acute Evaluation of Anatomical and&#xD;
      Geometric Changes using the Bladder on a Stick System (BOSS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">October 16, 2017</completion_date>
  <primary_completion_date type="Actual">October 16, 2017</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute anatomical changes assessed by echocardiography</measure>
    <time_frame>At Procedure</time_frame>
    <description>Anatomical annular and ventricular changes assessed by echocardiography, such as shape and deformation of the mitral valve annulus and left ventricular wall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute geometric changes measured by echocardiography</measure>
    <time_frame>At Procedure</time_frame>
    <description>Geometric annular and ventricular changes measured by echocardiography, such as reductions in septal-lateral dimension and left ventricular end diastolic diameter (LVEDD)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Functional Mitral Regurgitation</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>BOSS Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who are undergoing open chest cardiac surgery via sternotomy will receive the BOSS device to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BOSS Device</intervention_name>
    <description>The BOSS will be comprised of a flexible, medical grade silicone handle and interchangeable inflatable medical grade silicone chambers. The inflatable chambers will vary in geometry and will have silicone tubing attached to them to allow inflation and deflation of the chamber while in the pericardial space. During open chest cardiac surgery, a small incision will be made in the pericardium to allow for insertion of the BOSS device into the pericardial space. Once inserted, the BOSS device will be positioned in different locations around the outside of the heart and anatomical and geometric changes will be observed echocardiographically. Use of the BOSS device is expected to lengthen the procedure by an average of 15 minutes, and in rare instances may be extended beyond 15 minutes as deemed appropriate by the investigator. The BOSS will be removed prior to continuing with the planned surgery.</description>
    <arm_group_label>BOSS Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults ≥18 years of age&#xD;
&#xD;
          -  Patient undergoing open chest cardiac surgery via sternotomy&#xD;
&#xD;
          -  Signed informed consent by patient or legally authorized representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any procedure, condition or cardiac anatomy that may impact or compromise the&#xD;
             pericardial space (e.g. prior valve surgery, CABG, epicardial pacing leads,&#xD;
             pericarditis, history of mantle radiation, or other procedure involving pericardial&#xD;
             access)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Hase</last_name>
    <role>Study Director</role>
    <affiliation>Mardil Medical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Heart Institute at Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Italiano</name>
      <address>
        <city>Asuncion</city>
        <country>Paraguay</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Paraguay</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>April 2, 2018</last_update_submitted>
  <last_update_submitted_qc>April 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Functional Mitral Regurgitation</keyword>
  <keyword>Heart Failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Mitral Valve Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There are no plans to make individual participant data (IPD) available to other researchers.</ipd_description>
  </patient_data>
  <!-- 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/NCT03228381
org study id: BOSS CT005
nct id: NCT03228381
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The objective of the BOSS Study is to assess acute anatomical and geometric annular and
      ventricular changes that occur when strategically positioned an external inflatable chambers
      are applied to the outside of the heart.
Mardil Medical is developing an investigational device for functional mitral regurgitation
      intended to provide ventricular support with adjustable inflatable chambers to reduce annular
      dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation.
      In doing so, Mardil Medical is interested in exploring the anatomical and geometric annular
      and ventricular changes that occur when strategically positioned external inflatable chambers
      are applied to the outside of the heart. Favorable benefits of circumferential reduction in
      ventricular wall stress favoring left ventricular (LV) remodeling and acute reshaping of LV
      segments subtending the deformed mitral valve apparatus needs to be better understood. Mardil
      Medical is pursuing this study as an initial phase in the Acute Evaluation of Anatomical and
      Geometric Changes using the Bladder on a Stick System (BOSS).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Acute anatomical changes assessed by echocardiography
time frame: At Procedure
description: Anatomical annular and ventricular changes assessed by echocardiography, such as shape and deformation of the mitral valve annulus and left ventricular wall
measure: Acute geometric changes measured by echocardiography
time frame: At Procedure
description: Geometric annular and ventricular changes measured by echocardiography, such as reductions in septal-lateral dimension and left ventricular end diastolic diameter (LVEDD)
arm group label: BOSS Device
arm group type: Experimental
description: Patients who are undergoing open chest cardiac surgery via sternotomy will receive the BOSS device to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.
intervention type: Device
intervention name: BOSS Device
description: The BOSS will be comprised of a flexible, medical grade silicone handle and interchangeable inflatable medical grade silicone chambers. The inflatable chambers will vary in geometry and will have silicone tubing attached to them to allow inflation and deflation of the chamber while in the pericardial space. During open chest cardiac surgery, a small incision will be made in the pericardium to allow for insertion of the BOSS device into the pericardial space. Once inserted, the BOSS device will be positioned in different locations around the outside of the heart and anatomical and geometric changes will be observed echocardiographically. Use of the BOSS device is expected to lengthen the procedure by an average of 15 minutes, and in rare instances may be extended beyond 15 minutes as deemed appropriate by the investigator. The BOSS will be removed prior to continuing with the planned surgery.
arm group label: BOSS Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah Hase
role: Study Director
affiliation: Mardil Medical
facility: 
facility: 
facility: 
country: Paraguay
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Mitral Valve Insufficiency
sharing ipd: No
ipd description: There are no plans to make individual participant data (IPD) available to other researchers.