<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/NCT03278574</url>
  </required_header>
  <id_info>
    <org_study_id>25041214</org_study_id>
    <nct_id>NCT03278574</nct_id>
  </id_info>
  <brief_title>Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease</brief_title>
  <official_title>Mitral Valve Repair Using Flexible Bands Versus Complete Rings in Patients With Degenerative Mitral Valve Disease: a Prospective, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meshalkin Research Institute of Pathology of Circulation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meshalkin Research Institute of Pathology of Circulation</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 evaluates the results of mitral valve repair with flexible band in comparison with&#xD;
      rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, mitral ring selection is based on a surgeon's preference rather than evidence.&#xD;
      Semirigid rings combine flexibility and stability; however, their clinical benefit has not&#xD;
      been completely clarified. The present study aimed to compare the outcomes of mitral valve&#xD;
      repair with a flexible posterior annuloplasty band versus complete semirigid ring in patients&#xD;
      with degenerative mitral valve disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2011</start_date>
  <completion_date type="Actual">December 26, 2016</completion_date>
  <primary_completion_date type="Actual">September 29, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from significant mitral regurgitation</measure>
    <time_frame>12 months</time_frame>
    <description>Significant mitral regurgitation is defined as moderate and severe mitral regurgitation. The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>12 months, 24 months</time_frame>
    <description>Continued existence at follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from reoperations</measure>
    <time_frame>12 months, 24 months</time_frame>
    <description>Freedom from redo mitral valve surgery during follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from severe MR recurrence</measure>
    <time_frame>12 months</time_frame>
    <description>The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">171</enrollment>
  <condition>Mitral Regurgitation</condition>
  <arm_group>
    <arm_group_label>Flexible band</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mitral valve repair with flexible posterior annuloplasty band</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Complete ring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mitral valve repair with complete rigid ring</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mitral valve repair</intervention_name>
    <description>Mitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation</description>
    <arm_group_label>Complete ring</arm_group_label>
    <arm_group_label>Flexible band</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ring annuloplasty with posterior band</intervention_name>
    <description>Mitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band</description>
    <arm_group_label>Flexible band</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ring annuloplasty with complete ring</intervention_name>
    <description>Mitral valve annuloplasty using Cardiamed (Penza, Russia) complete semirigid ring</description>
    <arm_group_label>Complete ring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  severe primary mitral regurgitation due to degenerative mitral valve disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous open cardiac surgery,&#xD;
&#xD;
          -  indication for concomitant aortic valve replacement,&#xD;
&#xD;
          -  left ventricle impairment (ejection fraction &lt; 40%).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 10, 2017</last_update_submitted>
  <last_update_submitted_qc>September 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</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>
    <ipd_description>individual participant data is unavailable for security reason</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/NCT03278574
org study id: 25041214
nct id: NCT03278574
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluates the results of mitral valve repair with flexible band in comparison with
      rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease
Currently, mitral ring selection is based on a surgeon's preference rather than evidence.
      Semirigid rings combine flexibility and stability; however, their clinical benefit has not
      been completely clarified. The present study aimed to compare the outcomes of mitral valve
      repair with a flexible posterior annuloplasty band versus complete semirigid ring in patients
      with degenerative mitral valve disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Freedom from significant mitral regurgitation
time frame: 12 months
description: Significant mitral regurgitation is defined as moderate and severe mitral regurgitation. The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation
measure: Survival
time frame: 12 months, 24 months
description: Continued existence at follow up
measure: Freedom from reoperations
time frame: 12 months, 24 months
description: Freedom from redo mitral valve surgery during follow up
measure: Freedom from severe MR recurrence
time frame: 12 months
description: The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation
arm group label: Flexible band
arm group type: Experimental
description: Mitral valve repair with flexible posterior annuloplasty band
arm group label: Complete ring
arm group type: Active Comparator
description: Mitral valve repair with complete rigid ring
intervention type: Procedure
intervention name: Mitral valve repair
description: Mitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation
arm group label: Complete ring
arm group label: Flexible band
intervention type: Device
intervention name: Ring annuloplasty with posterior band
description: Mitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band
arm group label: Flexible band
intervention type: Device
intervention name: Ring annuloplasty with complete ring
description: Mitral valve annuloplasty using Cardiamed (Penza, Russia) complete semirigid ring
arm group label: Complete ring
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency
sharing ipd: No
ipd description: individual participant data is unavailable for security reason