<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/NCT03039855</url>
  </required_header>
  <id_info>
    <org_study_id>047-CPT-003</org_study_id>
    <nct_id>NCT03039855</nct_id>
  </id_info>
  <brief_title>Tiara™ Transcatheter Mitral Valve Replacement Study</brief_title>
  <acronym>TIARA-II</acronym>
  <official_title>Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neovasc Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neovasc Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve&#xD;
      with the Tiara Transapical Delivery System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The TIARA-II study is an international, multicenter, single-arm, prospective, safety and&#xD;
      performance clinical study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from all-cause mortality</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Freedom from major adverse events</measure>
    <time_frame>30 Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction of Mitral Regurgitation to optimal or acceptable</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from all-cause mortality</measure>
    <time_frame>90 days, 180 days, one year and annually to five years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from major adverse events</measure>
    <time_frame>90 days, 180 days, one year and annually to five years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>Day 0</time_frame>
    <description>Per MVARC criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success</measure>
    <time_frame>30 days</time_frame>
    <description>Per MVARC criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years</time_frame>
    <description>Per MVARC criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NYHA Functional Class</measure>
    <time_frame>30 days, 90 days, 180 days and once annually for five years</time_frame>
    <description>Number of subjects with improved NYHA class</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Minute Walk Test</measure>
    <time_frame>30 days, 90 days, 180 days and once annually for five years</time_frame>
    <description>Increase in distance (m) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kansas City Cardiomyopathy Questionnaire</measure>
    <time_frame>30 days, 90 days, 180 days and once annually for five years</time_frame>
    <description>Improvement in quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic performance</measure>
    <time_frame>30 days, 90 days, 180 days and once annually for five years</time_frame>
    <description>Assessed by echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient success</measure>
    <time_frame>1 year</time_frame>
    <description>Per MVARC Criteria</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">115</enrollment>
  <condition>Mitral Valve Regurgitation</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TIARA valve and transapical delivery system</intervention_name>
    <description>Transcatheter mitral valve replacement</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe mitral regurgitation&#xD;
&#xD;
          -  High surgical risk for open mitral valve surgery&#xD;
&#xD;
          -  Subject meets anatomical eligibility criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Deemed too frail by objective frailty assessments&#xD;
&#xD;
          -  Previous cardiac procedures: any mitral valve replacement surgery and cardiac&#xD;
             transplant&#xD;
&#xD;
          -  Unsuitable cardiac structure&#xD;
&#xD;
          -  Clinically significant untreated Coronary Artery Disease (CAD)&#xD;
&#xD;
          -  Subjects on chronic dialysis&#xD;
&#xD;
          -  Pregnant or planning pregnancy within next 12 months&#xD;
&#xD;
          -  Documented bleeding or coagulation disorders&#xD;
&#xD;
          -  Active infections requiring antibiotic therapy&#xD;
&#xD;
          -  Subjects with a life expectancy less than 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kerckhoff Klinik Herzzentrum-Herzchirurgie</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schüchtermann-Klinik</name>
      <address>
        <city>Bad Rothenfelde</city>
        <zip>49214</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deutches Herzzentrum Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Immanuel Klinikum Bernau und Herzzentrum Brandenburg</name>
      <address>
        <city>Bernau</city>
        <zip>16321</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.-Johannes-Hospital, Klinik für Innere Medizin I</name>
      <address>
        <city>Dortmund</city>
        <zip>44229</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Halle</name>
      <address>
        <city>Halle</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitasklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg</name>
      <address>
        <city>Rotenburg An Der Fulda</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana Herzchirurgie Stuttgart GmbH</name>
      <address>
        <city>Stuttgart</city>
        <zip>70174</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Toscana 'Gabriele Monasterio'</name>
      <address>
        <city>Massa</city>
        <zip>54100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Hospital</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edinburgh Heart Centre Royal Infirmary</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE59RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.neovasc.com</url>
    <description>Company website with product information</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mitral</keyword>
  <keyword>Regurgitation</keyword>
  <keyword>Heart valve</keyword>
  <keyword>Transcatheter</keyword>
  <keyword>Transapical</keyword>
  <keyword>Functional</keyword>
  <keyword>Degenerative</keyword>
  <keyword>TMVR</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/NCT03039855
org study id: 047-CPT-003
nct id: NCT03039855
lead sponsor: 
has dmc: Yes
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve
      with the Tiara Transapical Delivery System.
The TIARA-II study is an international, multicenter, single-arm, prospective, safety and
      performance clinical study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from all-cause mortality
time frame: 30 days
measure: Freedom from major adverse events
time frame: 30 Days
measure: Reduction of Mitral Regurgitation to optimal or acceptable
time frame: 30 days
measure: Freedom from all-cause mortality
time frame: 90 days, 180 days, one year and annually to five years
measure: Freedom from major adverse events
time frame: 90 days, 180 days, one year and annually to five years
measure: Technical success
time frame: Day 0
description: Per MVARC criteria
measure: Procedural success
time frame: 30 days
description: Per MVARC criteria
measure: Device success
time frame: Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years
description: Per MVARC criteria
measure: NYHA Functional Class
time frame: 30 days, 90 days, 180 days and once annually for five years
description: Number of subjects with improved NYHA class
measure: 6 Minute Walk Test
time frame: 30 days, 90 days, 180 days and once annually for five years
description: Increase in distance (m) from baseline
measure: Kansas City Cardiomyopathy Questionnaire
time frame: 30 days, 90 days, 180 days and once annually for five years
description: Improvement in quality of life
measure: Hemodynamic performance
time frame: 30 days, 90 days, 180 days and once annually for five years
description: Assessed by echocardiography
measure: Patient success
time frame: 1 year
description: Per MVARC Criteria
arm group label: Treatment
arm group type: Experimental
description: Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
intervention type: Device
intervention name: TIARA valve and transapical delivery system
description: Transcatheter mitral valve replacement
arm group label: Treatment
other name: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Israel
country: Italy
country: Netherlands
country: Spain
country: United Kingdom
url: http://www.neovasc.com
description: Company website with product information
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency