<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/NCT03292497</url>
  </required_header>
  <id_info>
    <org_study_id>20170700</org_study_id>
    <nct_id>NCT03292497</nct_id>
  </id_info>
  <brief_title>Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation</brief_title>
  <official_title>Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Heart Institute Research Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Heart Institute Research Corporation</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Ischemic mitral regurgitation is a disease where the mitral valve is regurgitant, or leaking,&#xD;
      as a result of changes in the muscle of the heart caused by coronary artery disease Ischemic&#xD;
      mitral regurgitation, or IMR, is normally treated by repairing or replacing the mitral valve.&#xD;
      Currently, we don't have very strong evidence showing which patients might benefit from&#xD;
      mitral valve repair and which might benefit from replacement, and surgeons tend to repair or&#xD;
      replace valves based on their preference or experience. Some surgeons, including Dr. Vincent&#xD;
      Chan, the Principal Investigator, believe that the decision to repair or replace the valve&#xD;
      should be based on specific measurements of the mitral valve. This study will randomly assign&#xD;
      patients to receive either the current standard of care for ischemic mitral regurgitation,&#xD;
      which is valve repair or replacement based on the surgeon's preference, or to have their&#xD;
      treatment decided by a set of criteria called an algorithm. This algorithm will assign&#xD;
      patients with certain mitral valve measurements to repair, and others to replacement.&#xD;
      Patients will be followed for 12 months after surgery, to compare whether patients whose&#xD;
      treatment was decided by the algorithm did better than patients whose treatment was decided&#xD;
      by surgeon preference.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 16, 2018</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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 (Outcomes Assessor)</masking>
    <masking_description>Echocardiographic outcome assessment will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Left ventricle end-systolic volume indexed to body surface area</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Comparison of changes in the indexed volume of the left ventricle.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in indexed left atrial volume</measure>
    <time_frame>Up to 12 months after surgery</time_frame>
    <description>Comparison of changes in the indexed volume of the left atrium.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in right ventricle systolic pressure</measure>
    <time_frame>Up to 12 months after surgery</time_frame>
    <description>Comparison of changes in the systolic pressure of the right ventricle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse events</measure>
    <time_frame>Up to 12 months after surgery</time_frame>
    <description>Composite endpoint of survival, recurrence of clinically-significant (&gt;= 2+) mitral regurgitation, and readmission to hospital for congestive heart failure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Mitral Regurgitation</condition>
  <arm_group>
    <arm_group_label>Treatment algorithm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mitral valve will be replaced if posterior leaflet tethering angle &gt;=25 degrees.&#xD;
Mitral valve will be repaired if posterior leaflet tethering angle &lt;25 degrees</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment algorithm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mitral valve will be repaired or replaced at surgeon's discretion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Treatment Algorithm</intervention_name>
    <description>Patients will have their procedure dictated by a treatment algorithm. They will have their mitral valve replaced if the posterior leaflet tethering angle &gt;=25 degrees, or repaired if the posterior leaflet tethering angle &lt;25 degrees.</description>
    <arm_group_label>Treatment algorithm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No Treatment Algorithm</intervention_name>
    <description>Patients will have their valve repaired or replaced at the discretion of their surgeon.</description>
    <arm_group_label>No treatment algorithm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe ischemic mitral valve regurgitation&#xD;
&#xD;
               -  18 years of age, and able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mixed mitral valve pathology&#xD;
&#xD;
          -  Acute ischemic mitral regurgitation&#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>Vincent Chan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Heart Institute Research Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 20, 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>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</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>
  <!-- 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/NCT03292497
org study id: 20170700
nct id: NCT03292497
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Ischemic mitral regurgitation is a disease where the mitral valve is regurgitant, or leaking,
      as a result of changes in the muscle of the heart caused by coronary artery disease Ischemic
      mitral regurgitation, or IMR, is normally treated by repairing or replacing the mitral valve.
      Currently, we don't have very strong evidence showing which patients might benefit from
      mitral valve repair and which might benefit from replacement, and surgeons tend to repair or
      replace valves based on their preference or experience. Some surgeons, including Dr. Vincent
      Chan, the Principal Investigator, believe that the decision to repair or replace the valve
      should be based on specific measurements of the mitral valve. This study will randomly assign
      patients to receive either the current standard of care for ischemic mitral regurgitation,
      which is valve repair or replacement based on the surgeon's preference, or to have their
      treatment decided by a set of criteria called an algorithm. This algorithm will assign
      patients with certain mitral valve measurements to repair, and others to replacement.
      Patients will be followed for 12 months after surgery, to compare whether patients whose
      treatment was decided by the algorithm did better than patients whose treatment was decided
      by surgeon preference.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Echocardiographic outcome assessment will be blinded.
measure: Left ventricle end-systolic volume indexed to body surface area
time frame: 12 months after surgery
description: Comparison of changes in the indexed volume of the left ventricle.
measure: Change in indexed left atrial volume
time frame: Up to 12 months after surgery
description: Comparison of changes in the indexed volume of the left atrium.
measure: Change in right ventricle systolic pressure
time frame: Up to 12 months after surgery
description: Comparison of changes in the systolic pressure of the right ventricle.
measure: Major adverse events
time frame: Up to 12 months after surgery
description: Composite endpoint of survival, recurrence of clinically-significant (>= 2+) mitral regurgitation, and readmission to hospital for congestive heart failure
arm group label: Treatment algorithm
arm group type: Experimental
description: Mitral valve will be replaced if posterior leaflet tethering angle >=25 degrees.
Mitral valve will be repaired if posterior leaflet tethering angle <25 degrees
arm group label: No treatment algorithm
arm group type: Active Comparator
description: Mitral valve will be repaired or replaced at surgeon's discretion.
intervention type: Procedure
intervention name: Treatment Algorithm
description: Patients will have their procedure dictated by a treatment algorithm. They will have their mitral valve replaced if the posterior leaflet tethering angle >=25 degrees, or repaired if the posterior leaflet tethering angle <25 degrees.
arm group label: Treatment algorithm
intervention type: Procedure
intervention name: No Treatment Algorithm
description: Patients will have their valve repaired or replaced at the discretion of their surgeon.
arm group label: No treatment algorithm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vincent Chan, MD
role: Principal Investigator
affiliation: Ottawa Heart Institute Research Corporation
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency