<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/NCT04483089</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-CIP-10317</org_study_id>
    <nct_id>NCT04483089</nct_id>
  </id_info>
  <brief_title>An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)</brief_title>
  <acronym>bRIGHT</acronym>
  <official_title>An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid&#xD;
      regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval&#xD;
      Study).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The TriClip™ bRIGHT EU post-approval study (PAS) study is designed to confirm the safety and&#xD;
      performance of the TriClip™ device in a contemporary real-world setting. The bRIGHT PAS study&#xD;
      is a prospective, single arm, open-label, multi-center, post market registry, conducted to&#xD;
      satisfy condition of CE Marking for the TriClip™.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 27, 2020</start_date>
  <completion_date type="Anticipated">January 2028</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2027</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>Acute Procedural Success (APS)</measure>
    <time_frame>up to 30 days</time_frame>
    <description>The primary endpoint is Acute Procedural Success (APS) defined as successful implantation of the TriClip™ device with resulting TR reduction at least 1 grade at discharge (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo tricuspid valve surgery before discharge are considered to be an APS failure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite endpoint of all-cause mortality or TR re-intervention</measure>
    <time_frame>at 1 year follow-up</time_frame>
    <description>The secondary endpoint is a composite endpoint of all-cause mortality or tricuspid valve re-intervention/re-operation at 1 year.</description>
  </secondary_outcome>
  <enrollment type="Actual">501</enrollment>
  <condition>Tricuspid Valve Regurgitation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcatheter heart valve procedure</intervention_name>
    <description>Transcatheter treatment of TR with Abbott TriClip™.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy&#xD;
        and are eligible to receive the TriClip™ per the current approved Indications For Use.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects (&gt;=18 years age) have severe tricuspid regurgitation and are symptomatic&#xD;
             despite medical therapy.&#xD;
&#xD;
          2. Subjects eligible to receive the TriClip™ per the current approved Indications for&#xD;
             Use.&#xD;
&#xD;
          3. Subject must provide written informed consent prior to study procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Subjects participating in another clinical study that may impact the follow-up or&#xD;
        results of this study.&#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>Erin Spinner</last_name>
    <role>Study Director</role>
    <affiliation>Clinical Program Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinik Graz</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Bonn</name>
      <address>
        <city>Bonn</city>
        <state>North Rhine-Westphalia</state>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsmedizin der Johannes Gutenberg-Universitat Mainz</name>
      <address>
        <city>Mainz</city>
        <state>Rhineland-Palatinate</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leipzig Heart Center</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentralklinik Bad Berka GmbH</name>
      <address>
        <city>Bad Berka</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz-und Diabetes Zentrum NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schüchtermann-Schiller´sche Kliniken GmbH &amp; Co. KG</name>
      <address>
        <city>Bad Rothenfelde</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRK Kliniken Köpenick</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.-Johannes-Hospital</name>
      <address>
        <city>Dortmund</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elisabeth-Krankenhaus Essen GmbH</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Katholisches Marienkrankenhaus GmbH</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UKE Hamburg (Universitatsklinik Eppendorf)</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Otto-von-Guericke-Universität Magdeburg</name>
      <address>
        <city>Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert-Bosch-Krankenhaus</name>
      <address>
        <city>Stuttgart</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maria Cecilia Hospital</name>
      <address>
        <city>Cotignola</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Monaldi</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita degli Studi di Padova</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Vila Nova de Gaia</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical and Provincial Hospital of Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Álvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HerzKlinik Hirslanden - Klinik Hirslanden</name>
      <address>
        <city>Zurich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 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>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/NCT04483089
org study id: ABT-CIP-10317
nct id: NCT04483089
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid
      regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval
      Study).
The TriClip™ bRIGHT EU post-approval study (PAS) study is designed to confirm the safety and
      performance of the TriClip™ device in a contemporary real-world setting. The bRIGHT PAS study
      is a prospective, single arm, open-label, multi-center, post market registry, conducted to
      satisfy condition of CE Marking for the TriClip™.
observational model: Cohort
time perspective: Prospective
measure: Acute Procedural Success (APS)
time frame: up to 30 days
description: The primary endpoint is Acute Procedural Success (APS) defined as successful implantation of the TriClip™ device with resulting TR reduction at least 1 grade at discharge (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo tricuspid valve surgery before discharge are considered to be an APS failure.
measure: Composite endpoint of all-cause mortality or TR re-intervention
time frame: at 1 year follow-up
description: The secondary endpoint is a composite endpoint of all-cause mortality or tricuspid valve re-intervention/re-operation at 1 year.
intervention type: Device
intervention name: Transcatheter heart valve procedure
description: Transcatheter treatment of TR with Abbott TriClip™.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erin Spinner
role: Study Director
affiliation: Clinical Program Director
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country: Austria
country: Denmark
country: Germany
country: Italy
country: Netherlands
country: Portugal
country: Spain
country: Switzerland
responsible party type: Sponsor
mesh term: Tricuspid Valve Insufficiency
sharing ipd: No