<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/NCT03290872</url>
  </required_header>
  <id_info>
    <org_study_id>14-7851</org_study_id>
    <nct_id>NCT03290872</nct_id>
  </id_info>
  <brief_title>Mitral Annuloplasty Rings RCT</brief_title>
  <official_title>A Study to Assess the Effects of Two Commonly Used Mitral Valve Annuloplasty Rings in Mitral Valve Repair on Short-term Outcomes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently published work has suggested that mitral valve annuloplasty ring type may affect the&#xD;
      development of post-repair mitral stenosis resulting in adverse intracardiac hemodynamics and&#xD;
      poor functional status. However, these results have not been comprehensively determined in a&#xD;
      systematic manner on a general mitral valve repair population. As well, an underlying&#xD;
      mechanism for these findings is not understood.&#xD;
&#xD;
      The investigators hypothesize that mitral valve repair with a complete annuloplasty ring&#xD;
      (Carpentier-Edwards Physio II) when compared to repair with a partial annuloplasty ring&#xD;
      (Simplici- T) may not necessarily result in elevated mitral gradients consistent with&#xD;
      functional mitral stenosis (FMS). Currently no prospective data exists to test the hypothesis&#xD;
      that a correctly sized, flexible complete annuloplasty ring has detrimental effects.&#xD;
&#xD;
      As 60% of annuloplasty rings used in surgical repair of degenerative mitral valve disease in&#xD;
      North America utilizes one of the many forms of complete flexible rings available, this&#xD;
      information is urgently required.&#xD;
&#xD;
      The investigators will evaluate: 1) the effect on mitral valve hemodynamics, 2) changes to&#xD;
      mitral annular, valvular and subvalvular structure and function with 3D echocardiography, and&#xD;
      3) the effect on patient functional capacity at 1 year.&#xD;
&#xD;
      If FMS early post repair is a real phenomenon, the investigators hope to better understand&#xD;
      the mechanisms through the use of advanced imaging techniques-namely 3D modeling of the&#xD;
      mitral valvular apparatus, aortic mitral interactions and LV remodeling.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean mitral valve gradient</measure>
    <time_frame>1 year</time_frame>
    <description>Mean mitral valve gradient measured by transthoracic echocardiogram</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Left ventricular remodelling</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment of left ventricular remodelling obtained from transthoracic echocardiography performed pre-operatively and at 1 year post surgery using 3D LV end-diastolic volume and 3D end-systolic volume measurements and 3D LV ejection fraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aortic-mitral coupling</measure>
    <time_frame>1 year</time_frame>
    <description>3D transesophageal echocardiogram assessment intra-operatively both pre and post bypass assessing the entire mitral valvular and subvalvular apparatus, the left ventricle and the aortic valve to assess aortic-mitral valvular coupling and to determine whether there is a difference observed in aorto-mitral coupling between complete and partial ring repairs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional capacity</measure>
    <time_frame>1 year</time_frame>
    <description>Functional capacity will be specifically assessed using workload achieved on stress transthoracic echocardiogram studies performed pre surgery and at 1 year post surgery. Measurements acquired will include total exercise time and total workload achieved. Also patients will complete SF-36 questionnaires pre-surgery and at 1 year post surgery for further assessment of change in functional capacity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Degenerative Mitral Valve Disease</condition>
  <arm_group>
    <arm_group_label>Carpentier Edwards Physio 2 Complete flexible mitral ring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mitral Valve Annuloplasty Ring Repair using Carpentier Edwards Physio 2 Complete flexible mitral ring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simplici T Partial flexible mitral annuloplasty ring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mitral Valve Annuloplasty Ring Repair using Simplici T Partial flexible mitral annuloplasty ring</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Carpentier Edwards Physio 2 Complete flexible mitral ring</intervention_name>
    <description>Mitral valve Annuloplasty Ring repair using a Carpentier Edwards Physio 2 Complete flexible mitral ring</description>
    <arm_group_label>Carpentier Edwards Physio 2 Complete flexible mitral ring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Simplici T Partial flexible mitral annuloplasty ring</intervention_name>
    <description>Mitral valve Annuloplasty Ring repair using a Simplici T Partial flexible mitral annuloplasty ring</description>
    <arm_group_label>Simplici T Partial flexible mitral annuloplasty ring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mitral regurgitation secondary to degenerative valve disease referred to Prof Tirone&#xD;
             David (Co-investigator) will be invited to take part.&#xD;
&#xD;
          -  The mitral valve anatomy must be anatomy suitable for repair.&#xD;
&#xD;
          -  The patient must be able to perform treadmill exercise echocardiography.&#xD;
&#xD;
          -  The patient must be over 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any presence of life-limiting disease process, for example advanced malignancy.&#xD;
&#xD;
          -  Hemodynamically unstable patients in cardiogenic shock&#xD;
&#xD;
          -  Concomitant aortic valve disease/surgery&#xD;
&#xD;
          -  Previous mitral valve repair&#xD;
&#xD;
          -  Impaired left ventricular systolic function as defined by a left ventricular ejection&#xD;
             fraction of ≤ 50%.&#xD;
&#xD;
          -  If the patient lives out of state or cannot attend follow up visits.&#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>Wendy W Tsang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wendy W Tsang, MD</last_name>
    <phone>4163403155</phone>
    <email>Wendy.Tsang@uhn.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kate H Rankin, MBBS</last_name>
    <phone>4163403155</phone>
    <email>kate.rankin@uhn.ca</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03290872
org study id: 14-7851
nct id: NCT03290872
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Recently published work has suggested that mitral valve annuloplasty ring type may affect the
      development of post-repair mitral stenosis resulting in adverse intracardiac hemodynamics and
      poor functional status. However, these results have not been comprehensively determined in a
      systematic manner on a general mitral valve repair population. As well, an underlying
      mechanism for these findings is not understood.

      The investigators hypothesize that mitral valve repair with a complete annuloplasty ring
      (Carpentier-Edwards Physio II) when compared to repair with a partial annuloplasty ring
      (Simplici- T) may not necessarily result in elevated mitral gradients consistent with
      functional mitral stenosis (FMS). Currently no prospective data exists to test the hypothesis
      that a correctly sized, flexible complete annuloplasty ring has detrimental effects.

      As 60% of annuloplasty rings used in surgical repair of degenerative mitral valve disease in
      North America utilizes one of the many forms of complete flexible rings available, this
      information is urgently required.

      The investigators will evaluate: 1) the effect on mitral valve hemodynamics, 2) changes to
      mitral annular, valvular and subvalvular structure and function with 3D echocardiography, and
      3) the effect on patient functional capacity at 1 year.

      If FMS early post repair is a real phenomenon, the investigators hope to better understand
      the mechanisms through the use of advanced imaging techniques-namely 3D modeling of the
      mitral valvular apparatus, aortic mitral interactions and LV remodeling.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Mean mitral valve gradient
time frame: 1 year
description: Mean mitral valve gradient measured by transthoracic echocardiogram
measure: Left ventricular remodelling
time frame: 1 year
description: Assessment of left ventricular remodelling obtained from transthoracic echocardiography performed pre-operatively and at 1 year post surgery using 3D LV end-diastolic volume and 3D end-systolic volume measurements and 3D LV ejection fraction
measure: Aortic-mitral coupling
time frame: 1 year
description: 3D transesophageal echocardiogram assessment intra-operatively both pre and post bypass assessing the entire mitral valvular and subvalvular apparatus, the left ventricle and the aortic valve to assess aortic-mitral valvular coupling and to determine whether there is a difference observed in aorto-mitral coupling between complete and partial ring repairs
measure: Change in functional capacity
time frame: 1 year
description: Functional capacity will be specifically assessed using workload achieved on stress transthoracic echocardiogram studies performed pre surgery and at 1 year post surgery. Measurements acquired will include total exercise time and total workload achieved. Also patients will complete SF-36 questionnaires pre-surgery and at 1 year post surgery for further assessment of change in functional capacity
arm group label: Carpentier Edwards Physio 2 Complete flexible mitral ring
arm group type: Active Comparator
description: Mitral Valve Annuloplasty Ring Repair using Carpentier Edwards Physio 2 Complete flexible mitral ring
arm group label: Simplici T Partial flexible mitral annuloplasty ring
arm group type: Active Comparator
description: Mitral Valve Annuloplasty Ring Repair using Simplici T Partial flexible mitral annuloplasty ring
intervention type: Device
intervention name: Carpentier Edwards Physio 2 Complete flexible mitral ring
description: Mitral valve Annuloplasty Ring repair using a Carpentier Edwards Physio 2 Complete flexible mitral ring
arm group label: Carpentier Edwards Physio 2 Complete flexible mitral ring
intervention type: Device
intervention name: Simplici T Partial flexible mitral annuloplasty ring
description: Mitral valve Annuloplasty Ring repair using a Simplici T Partial flexible mitral annuloplasty ring
arm group label: Simplici T Partial flexible mitral annuloplasty ring
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wendy W Tsang, MD
role: Principal Investigator
affiliation: University Health Network, Toronto General Hospital
last name: Wendy W Tsang, MD
phone: 4163403155
email: Wendy.Tsang@uhn.ca
last name: Kate H Rankin, MBBS
phone: 4163403155
email: kate.rankin@uhn.ca
responsible party type: Sponsor
sharing ipd: No