<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/NCT04418960</url>
  </required_header>
  <id_info>
    <org_study_id>2018-02240; ch20Grapow</org_study_id>
    <nct_id>NCT04418960</nct_id>
  </id_info>
  <brief_title>Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease</brief_title>
  <official_title>Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease: an MRI-focused Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      Barlow disease (BD) is a common cause of mitral insufficiency. In 2012 the University&#xD;
      Hospital of Basel started to perform a simplified mitral valve repair technique in BD just by&#xD;
      implanting an annuloplasty-ring. It is hypothesized that the major mechanism of the valvular&#xD;
      insufficiency in Barlow disease is a deformation of the left ventricle and the posterior&#xD;
      mitral annulus, causing its aberrant displacement during the systole towards posterior and&#xD;
      basal and thus impairing the coaptation of the leaflets. This prospective individual MRI&#xD;
      study is to investigate the ventricle and the mitral annulus pre- and postoperatively for&#xD;
      detailed analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 21, 2018</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in anatomical structures by MRI</measure>
    <time_frame>The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation.</time_frame>
    <description>Change in anatomical structures by MRI: distance (mm) between the mitral annulus and the cardiac apex during the cardiac cycle before and after surgical correction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>function of the mitral valve by echocardiography</measure>
    <time_frame>during the hospital stay, between 3 and 7 days after the operation and at cardiological follow-up over the first 3 months.</time_frame>
    <description>association between reduction of movement of the posterior annulus and the function of the valve after surgery (i.e. its residual insufficiency (0 = absent, 1 = mild, 2 = moderate, 3 = severe)). Evaluated with echocardiography as it is routinely performed in cardiac surgery.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Barlow Disease (BD)</condition>
  <condition>Mitral Insufficiency</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Magnetic resonance imaging (MRI)</intervention_name>
    <description>MRI pre- and postoperatively for detailed analysis of the ventricle and the mitral annulus. The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation. The MRI images are interpreted through a specialized cardiologist and radiologist.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred to cardiac surgery clinic (University Hospital Basel) through&#xD;
        cardiologist meeting the inclusion criteria based on the medical history, clinical and&#xD;
        echocardiographic findings.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  identified Barlow disease suffering from significant mitral insufficiency with&#xD;
             indication to surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active endocarditis or any other etiology of mitral insufficiency else than Barlow&#xD;
             disease&#xD;
&#xD;
          -  Inability to perform a cardiac MRI (e.g., metallic implants, claustrophobia)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability to give consent&#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>Martin Grapow, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>HerzZentrum Hirslanden, Zurich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martin Grapow, Prof. Dr. med.</last_name>
    <phone>+41 44 3873711</phone>
    <email>grapow@herzzentrum.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thibault Schaeffer</last_name>
    <phone>+41 61 328766</phone>
    <email>Thibault.schaeffer@usb.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cardiac Surgery, University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Grapow, Prof. Dr. med.</last_name>
      <phone>+41 44 3873711</phone>
      <email>grapow@herzzentrum.ch</email>
    </contact>
    <contact_backup>
      <last_name>Thibault Schaeffer</last_name>
      <phone>+41 61 3285766</phone>
      <email>Thibault.Schaeffer@usb.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mitral annuloplasty</keyword>
  <keyword>mitral valve repair</keyword>
  <keyword>mitral annulus</keyword>
  <keyword>coaptation of mitral leaflets</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitral Valve Insufficiency</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/NCT04418960
org study id: 2018-02240; ch20Grapow
nct id: NCT04418960
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Barlow disease (BD) is a common cause of mitral insufficiency. In 2012 the University
      Hospital of Basel started to perform a simplified mitral valve repair technique in BD just by
      implanting an annuloplasty-ring. It is hypothesized that the major mechanism of the valvular
      insufficiency in Barlow disease is a deformation of the left ventricle and the posterior
      mitral annulus, causing its aberrant displacement during the systole towards posterior and
      basal and thus impairing the coaptation of the leaflets. This prospective individual MRI
      study is to investigate the ventricle and the mitral annulus pre- and postoperatively for
      detailed analysis.
observational model: Cohort
time perspective: Prospective
measure: Change in anatomical structures by MRI
time frame: The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation.
description: Change in anatomical structures by MRI: distance (mm) between the mitral annulus and the cardiac apex during the cardiac cycle before and after surgical correction
measure: function of the mitral valve by echocardiography
time frame: during the hospital stay, between 3 and 7 days after the operation and at cardiological follow-up over the first 3 months.
description: association between reduction of movement of the posterior annulus and the function of the valve after surgery (i.e. its residual insufficiency (0 = absent, 1 = mild, 2 = moderate, 3 = severe)). Evaluated with echocardiography as it is routinely performed in cardiac surgery.
intervention type: Diagnostic Test
intervention name: Magnetic resonance imaging (MRI)
description: MRI pre- and postoperatively for detailed analysis of the ventricle and the mitral annulus. The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation. The MRI images are interpreted through a specialized cardiologist and radiologist.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Grapow, Prof. Dr. med.
role: Principal Investigator
affiliation: HerzZentrum Hirslanden, Zurich
last name: Martin Grapow, Prof. Dr. med.
phone: +41 44 3873711
email: grapow@herzzentrum.ch
last name: Thibault Schaeffer
phone: +41 61 328766
email: Thibault.schaeffer@usb.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency