<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/NCT03779490</url>
  </required_header>
  <id_info>
    <org_study_id>2017-21</org_study_id>
    <nct_id>NCT03779490</nct_id>
  </id_info>
  <brief_title>Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)</brief_title>
  <acronym>TriBAND</acronym>
  <official_title>Transcatheter Repair of Tricuspid Regurgitation With Cardioband TR System Post-Market Clinical Follow-Up Study (TriBAND): A European Prospective, Multicenter Post-market Clinical Follow-up Study to Assess Transcatheter Tricuspid Valve Repair With Edwards Cardioband TR System in Patients With Symptomatic Chronic Functional Tricuspid Regurgitation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Edwards Lifesciences</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>
      The purpose of the study is to assess the safety and the effectiveness of the Cardioband&#xD;
      Tricuspid Reconstruction System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to assess the safety and the effectiveness of the Cardioband&#xD;
      Tricuspid Reconstruction System. This is a multi-center, prospective, single-arm Post-Market&#xD;
      Clinical Follow up Study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 24, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Actual">September 30, 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>Procedure Success</measure>
    <time_frame>Hospital discharge, 2-7 days post-procedure</time_frame>
    <description>Reduction in severity of Tricuspid Regurgitation at discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Event Rate</measure>
    <time_frame>30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years</time_frame>
    <description>Rates of major adverse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Success</measure>
    <time_frame>30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years</time_frame>
    <description>Reduction in severity of Tricuspid Regurgitation (TR) severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life - KCCQ</measure>
    <time_frame>30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years</time_frame>
    <description>Improvement in Quality of Life as assessed by KCCQ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life - EQ-5D-5L</measure>
    <time_frame>30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years</time_frame>
    <description>Improvement in Quality of Life as assessed by EQ-5D-5L</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Tricuspid Regurgitation</condition>
  <condition>Tricuspid Insufficiency</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcatheter Tricuspid Valve Repair</intervention_name>
    <description>Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Symptomatic patients with chronic functional tricuspid regurgitation (FTR)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  Inclusion Criteria:&#xD;
&#xD;
               -  Eighteen (18) years of age or older&#xD;
&#xD;
               -  Moderate or greater functional Tricuspid Regurgitation (TR)&#xD;
&#xD;
               -  Patient is eligible to receive the Edwards Cardioband TR System per the current&#xD;
                  approved indications for use.&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
               -  Patients deemed anatomically unsuitable for the device by echocardiography&#xD;
&#xD;
               -  Patients in whom transesophageal echocardiography (TEE) is contraindicated&#xD;
&#xD;
               -  Previous tricuspid valve repair or replacement&#xD;
&#xD;
               -  Severe aortic, mitral and / or pulmonic valve stenosis&#xD;
&#xD;
               -  Severe aortic, mitral and / or pulmonic valve regurgitation&#xD;
&#xD;
               -  Renal Insufficiency requiring dialysis or severe kidney renal disease&#xD;
&#xD;
               -  Life expectancy of less than twelve months&#xD;
&#xD;
               -  Patient is pregnant or lactating&#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>Georg Nickenig, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Bonn, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ulm University</name>
      <address>
        <city>Ulm</city>
        <state>Bayern</state>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik der Ruhr-Universität Bochum</name>
      <address>
        <city>Bad Oeynhausen</city>
        <state>North Rhine Westphalia</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum der UniKlinik Köln</name>
      <address>
        <city>Cologne</city>
        <state>NRW</state>
        <zip>50924</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Campus Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berlin Charité-Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>51312</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Universitätsklinik Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Göttingen, Herzzentrum Göttingen</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik St. Georg</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UKE Hamburg</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Katholisches Marienkrankenhaus</name>
      <address>
        <city>Hamburg</city>
        <zip>22087</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cahal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Bern (Inselspital)</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Spain</country>
    <country>Switzerland</country>
  </location_countries>
  <removed_countries>
    <country>Sweden</country>
  </removed_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Edwards Cardioband TR</keyword>
  <keyword>Annuloplasty</keyword>
  <keyword>Tricuspid Repair</keyword>
  <keyword>Tricuspid Valve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tricuspid Valve Insufficiency</mesh_term>
  </condition_browse>
  <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/NCT03779490
org study id: 2017-21
nct id: NCT03779490
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of the study is to assess the safety and the effectiveness of the Cardioband
      Tricuspid Reconstruction System.
The purpose of the study is to assess the safety and the effectiveness of the Cardioband
      Tricuspid Reconstruction System. This is a multi-center, prospective, single-arm Post-Market
      Clinical Follow up Study.
observational model: Cohort
time perspective: Prospective
measure: Procedure Success
time frame: Hospital discharge, 2-7 days post-procedure
description: Reduction in severity of Tricuspid Regurgitation at discharge.
measure: Major Adverse Event Rate
time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
description: Rates of major adverse
measure: Procedure Success
time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
description: Reduction in severity of Tricuspid Regurgitation (TR) severity
measure: Change in Quality of Life - KCCQ
time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
description: Improvement in Quality of Life as assessed by KCCQ.
measure: Change in Quality of Life - EQ-5D-5L
time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
description: Improvement in Quality of Life as assessed by EQ-5D-5L
intervention type: Device
intervention name: Transcatheter Tricuspid Valve Repair
description: Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Georg Nickenig, MD
role: Principal Investigator
affiliation: Universitätsklinikum Bonn, Germany
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Spain
country: Switzerland
country: Sweden
responsible party type: Sponsor
mesh term: Tricuspid Valve Insufficiency
sharing ipd: No