<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/NCT03286088</url>
  </required_header>
  <id_info>
    <org_study_id>ICBE-2-15217</org_study_id>
    <nct_id>NCT03286088</nct_id>
  </id_info>
  <brief_title>Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection</brief_title>
  <official_title>Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Electronics Nederland B.V. acting through Philips CTO organization</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Electronics Nederland B.V. acting through Philips CTO organization</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>
      The study primarily aims to collect standard of care clinical data in a wide spectrum of&#xD;
      simple to complex mitral valve regurgitation (MVR) cases to validate a post-processing&#xD;
      stand-alone software prototype (QFlow), developed by Philips Research Paris (Medisys).&#xD;
&#xD;
      Investigator does not intervene in the care of the patient, but simply collects standard of&#xD;
      care images and measurements that are needed for the validation of the investigational&#xD;
      software.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Central diastolic and systolic blood pressures</measure>
    <time_frame>Day 1</time_frame>
    <description>images and measurements</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Mitral Valve Regurgitation of Any Grade</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>TransEsophageal Echocardiography + TransThoracic Echocardiography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>TransEsophageal Echocardiography and TransEsophageal Echocardiography</intervention_name>
    <description>imaging as standard practice</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cardiac Magnetics Resonance</intervention_name>
    <description>imaging as standard practice</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MitraClip</intervention_name>
    <description>imaging as standard practice</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  both genders&#xD;
&#xD;
          -  age between 18 and 85 years old (adult, senior)&#xD;
&#xD;
          -  sinus rhythm&#xD;
&#xD;
          -  hHemodynamic stable&#xD;
&#xD;
          -  mitral valve regurgitation (MVR) of any grade i.e., from mild to severe as determined&#xD;
             by assessment of a qualifying TransThoracic Echocardiography (TTE) exam at Saint-Luc&#xD;
             University Hospital&#xD;
&#xD;
          -  scheduled for TransEsophageal Echocardiography (TEE) at Saint-Luc University Hospital,&#xD;
             as part of the subject's routine standard of care&#xD;
&#xD;
          -  subjects has functional capacity to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  subject lacks functional capacity to give written informed consent belongs to a&#xD;
             vulnerable population per investigator's judgment or subject has any kind of disorder&#xD;
             that compromises his/her ability to give written informed consent and/or to comply&#xD;
             with study procedures&#xD;
&#xD;
        Among the120 subjects, there will be three (3) sub-groups as follows:&#xD;
&#xD;
          -  a first sub-group (A) of 50 subjects with all inclusion criteria and none of the&#xD;
             exclusion criteria&#xD;
&#xD;
          -  a second sub-group (B) of 50 subjects with additional inclusion criterion: scheduled&#xD;
             for cardiac Magnetic Resonance (cMR), as part of the subject's routine standard of&#xD;
             care&#xD;
&#xD;
          -  a third sub-group (C) of 20 subjects with additional inclusion criterion: scheduled&#xD;
             for MitraClip transcatheter mitral valve repair (MitraClip) procedure as part of the&#xD;
             subject's routine standard of care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Saint Luc University Hospital</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>March 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2021</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>Mitral Valve Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03286088
org study id: ICBE-2-15217
nct id: NCT03286088
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study primarily aims to collect standard of care clinical data in a wide spectrum of
      simple to complex mitral valve regurgitation (MVR) cases to validate a post-processing
      stand-alone software prototype (QFlow), developed by Philips Research Paris (Medisys).

      Investigator does not intervene in the care of the patient, but simply collects standard of
      care images and measurements that are needed for the validation of the investigational
      software.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Central diastolic and systolic blood pressures
time frame: Day 1
description: images and measurements
arm group label: Group A
arm group type: Other
description: TransEsophageal Echocardiography + TransThoracic Echocardiography
arm group label: Group B
arm group type: Other
description: TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance
arm group label: Group C
arm group type: Other
description: TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip
intervention type: Diagnostic Test
intervention name: TransEsophageal Echocardiography and TransEsophageal Echocardiography
description: imaging as standard practice
arm group label: Group A
arm group label: Group B
arm group label: Group C
intervention type: Diagnostic Test
intervention name: Cardiac Magnetics Resonance
description: imaging as standard practice
arm group label: Group B
intervention type: Diagnostic Test
intervention name: MitraClip
description: imaging as standard practice
arm group label: Group C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency
sharing ipd: No