<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/NCT03227757</url>
  </required_header>
  <id_info>
    <org_study_id>16-517</org_study_id>
    <nct_id>NCT03227757</nct_id>
  </id_info>
  <brief_title>TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR</brief_title>
  <acronym>TRILUMINATE</acronym>
  <official_title>Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid&#xD;
      Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid&#xD;
      regurgitation (TR) in patients currently on medical management and who are deemed appropriate&#xD;
      for percutaneous transcatheter intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single arm, multi-center study.&#xD;
&#xD;
      A minimum of 85 subjects will be prospectively enrolled into this single arm study in&#xD;
      approximately 25 sites, in Europe, Canada and the United States. Patients will be seen for&#xD;
      follow-up visits at discharge (≤ 7 days post index procedure), 30 days, 6 months, 1,2,3&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">June 9, 2024</completion_date>
  <primary_completion_date type="Actual">November 14, 2019</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>Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade</measure>
    <time_frame>At 30 days</time_frame>
    <description>Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Composite of Major Adverse Event (MAE)</measure>
    <time_frame>At 6 months</time_frame>
    <description>Major Adverse Event (MAE) is defined as a composite of:&#xD;
Cardiovascular Mortality&#xD;
Myocardial Infarction (MI)&#xD;
Stroke&#xD;
New onset renal failure&#xD;
Endocarditis requiring surgery, and&#xD;
Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Tricuspid Valve Insufficiency</condition>
  <arm_group>
    <arm_group_label>Tricuspid Valve Repair System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who received TVRS will be included in this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tricuspid Valve Repair System</intervention_name>
    <description>Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.</description>
    <arm_group_label>Tricuspid Valve Repair System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be ≥18 years and ≤ 90 years at time of consent and must not be a member&#xD;
             of a vulnerable population.&#xD;
&#xD;
          2. Subject or a legally authorized representative (where allowed per local regulations)&#xD;
             must provide written informed consent prior to any trial related procedure.&#xD;
&#xD;
          3. Subject must agree not to participate in any other clinical trial for a period of one&#xD;
             year following the index procedure.&#xD;
&#xD;
          4. In the judgment of the investigator at the site, the subject has been adequately&#xD;
             treated per applicable standards, including for coronary artery disease, mitral&#xD;
             regurgitation and heart failure at least 30-days prior to index procedure. The&#xD;
             Eligibility Committee must concur that the subject has been adequately treated.&#xD;
&#xD;
          5. New York Heart Association (NYHA) Functional Class II (conditional), III, or&#xD;
             ambulatory IV&#xD;
&#xD;
               1. Subjects with moderate TR: Only NYHA Class III or IV may be considered&#xD;
&#xD;
               2. Subjects with severe or greater TR: NYHA II, III, or IV may be considered for&#xD;
                  inclusion&#xD;
&#xD;
          6. No indication for left-sided or pulmonary valve correction.&#xD;
&#xD;
          7. The Site Heart Team concur the benefit-risk analysis supports intervention for&#xD;
             tricuspid regurgitation per current guidelines for the management of Valvular heart&#xD;
             disease and that the subject is at high risk for tricuspid valve surgery.&#xD;
&#xD;
          8. In the judgement of the TVRS implanting investigator, femoral vein access is&#xD;
             determined to be feasible and can accommodate a 25 Fr catheter.&#xD;
&#xD;
             Echocardiographic Inclusion Criteria:&#xD;
&#xD;
          9. Moderate or greater (≥2+) Tricuspid Regurgitation determined by the assessment of a&#xD;
             qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)&#xD;
             confirmed by the Echocardiography Core Lab (ECL).&#xD;
&#xD;
         10. Tricuspid valve anatomy determined to be suitable for implantation determined by the&#xD;
             site heart team.&#xD;
&#xD;
         11. Tricuspid valve anatomy evaluable by TTE and TEE.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is currently participating in another clinical trial that has not yet&#xD;
             completed its primary endpoint.&#xD;
&#xD;
          2. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year&#xD;
             following index procedure. Female subjects of child-bearing potential must have a&#xD;
             negative pregnancy test done within 7 days prior to the index procedure per site&#xD;
             standard test.&#xD;
&#xD;
          3. Severe uncontrolled hypertension (Systolic blood pressure [SBP] ≥ 180 mmHg and/or&#xD;
             Diastolic blood pressure [DBP] ≥ 110 mm Hg).&#xD;
&#xD;
          4. Systolic Pulmonary Artery Pressure &gt; 60 mmHg (echo determined).&#xD;
&#xD;
          5. Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid&#xD;
             valve, or any prior transcatheter tricuspid valve procedure.&#xD;
&#xD;
          6. Mitral Regurgitation moderate-severe or greater severity (≥3+).&#xD;
&#xD;
          7. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent&#xD;
             appropriate placement of TVRS Clip.&#xD;
&#xD;
          8. Active endocarditis or active rheumatic heart disease or leaflets degenerated from&#xD;
             rheumatic disease.&#xD;
&#xD;
          9. Myocardial Infarction (MI) or known unstable angina within prior 30 days prior to&#xD;
             enrollment.&#xD;
&#xD;
         10. Percutaneous coronary intervention within prior 30 days prior to enrollment.&#xD;
&#xD;
         11. Hemodynamic instability defined as systolic pressure &lt; 90 mmHg with or without&#xD;
             afterload reduction, cardiogenic shock or the need for inotropic support or&#xD;
             intra-aortic balloon pump or other hemodynamic support device.&#xD;
&#xD;
         12. Cerebrovascular Accident (CVA) within prior 3 months to enrollment.&#xD;
&#xD;
         13. Chronic dialysis.&#xD;
&#xD;
         14. Bleeding disorders or hypercoagulable state.&#xD;
&#xD;
         15. Active peptic ulcer or active gastrointestinal (GI) bleeding.&#xD;
&#xD;
         16. Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant&#xD;
             therapy.&#xD;
&#xD;
         17. Active infections requiring current antibiotic therapy (if temporary illness, patients&#xD;
             may enroll 4 weeks after discontinuation of antibiotics with no active infection).&#xD;
&#xD;
         18. Known allergy or hypersensitivity to device materials.&#xD;
&#xD;
         19. In the judgement of the investigator, a condition that could limit a patient's ability&#xD;
             or unwillingness to participate in the study, comply with study required testing&#xD;
             and/or follow-up visits or that could impact scientific integrity of the study.&#xD;
&#xD;
         20. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus&#xD;
             or vegetation.&#xD;
&#xD;
         21. Life expectancy of less than 12 months due to non-cardiac conditions.&#xD;
&#xD;
             Echocardiographic Exclusion Criteria:&#xD;
&#xD;
         22. Tricuspid stenosis.&#xD;
&#xD;
         23. Left Ventricular Ejection Fraction (LVEF) ≤20%.&#xD;
&#xD;
         24. Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip&#xD;
             positioning on the leaflets or sufficient reduction in TR. This may include:&#xD;
&#xD;
               1. Evidence of calcification in the grasping area&#xD;
&#xD;
               2. Presence of a severe coaptation defect (&gt; 2cm) of the tricuspid leaflets&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prof. Georg Nickenig</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bonn</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nord Laennec - Chu De Nantes</name>
      <address>
        <city>Nantes</city>
        <state>Saint-Herblain</state>
        <zip>44 093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bichat-Claude Bernard Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ludwig-Maximilian University of Munich (LMU)</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schuchtermann Klinik</name>
      <address>
        <city>Bad Rothenfelde</city>
        <state>Lower Saxony</state>
        <zip>49214</zip>
        <country>Germany</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>Albertinen-Krankenhaus</name>
      <address>
        <city>Hamburg</city>
        <zip>22457</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto</name>
      <address>
        <city>Catania</city>
        <state>Catania (CT)</state>
        <zip>95124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Raffaele University Hospital</name>
      <address>
        <city>Milano</city>
        <state>Milan</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Sant'Ambrogio</name>
      <address>
        <city>Milano</city>
        <state>Milan</state>
        <zip>20149</zip>
        <country>Italy</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>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>
    <facility>
      <name>University Hospital of Zurich (USZ)</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <results_first_submitted>August 9, 2021</results_first_submitted>
  <results_first_submitted_qc>October 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 26, 2021</results_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TRILUMINATE</keyword>
  <keyword>Percutaneous transcatheter intervention</keyword>
  <keyword>Tricuspid regurgitation</keyword>
  <keyword>Tricuspid Valve Repair System</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03227757/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03227757/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 85 subjects were enrolled and underwent Tricuspid Valve Repair System (TVRS) procedure.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Tricuspid Valve Repair System</title>
          <description>Subjects who received TVRS will be included in this arm.&#xD;
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed visits</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tricuspid Valve Repair System</title>
          <description>Subjects who received TVRS will be included in this arm.&#xD;
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="85"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77.8" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Switzerland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>New York Heart Association (NYHA) class II or above</title>
          <description>NYHA functional classification system relates symptoms to everyday activities and the patient's quality of life.&#xD;
NYHA Class I: Subjects with cardiac disease but without resulting limitations of physical activity.&#xD;
NYHA Class II: Subjects with cardiac disease resulting in slight limitation of physical activity.&#xD;
NYHA Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.&#xD;
NYHA Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>NYHA class II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NYHA class III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NYHA class IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade</title>
        <description>Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.</description>
        <time_frame>At 30 days</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Tricuspid Valve Repair System</title>
            <description>Subjects who received TVRS will be included in this arm.&#xD;
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade</title>
          <description>Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Composite of Major Adverse Event (MAE)</title>
        <description>Major Adverse Event (MAE) is defined as a composite of:&#xD;
Cardiovascular Mortality&#xD;
Myocardial Infarction (MI)&#xD;
Stroke&#xD;
New onset renal failure&#xD;
Endocarditis requiring surgery, and&#xD;
Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure</description>
        <time_frame>At 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Tricuspid Valve Repair System</title>
            <description>Subjects who received TVRS will be included in this arm.&#xD;
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Composite of Major Adverse Event (MAE)</title>
          <description>Major Adverse Event (MAE) is defined as a composite of:&#xD;
Cardiovascular Mortality&#xD;
Myocardial Infarction (MI)&#xD;
Stroke&#xD;
New onset renal failure&#xD;
Endocarditis requiring surgery, and&#xD;
Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tricuspid Valve Repair System</title>
          <description>Subjects who received TVRS will be included in this arm.&#xD;
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Cardiorenal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Sick sinus syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Gastritis haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Oesophagitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Medical device complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Multi-organ failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Gallbladder empyema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Ejection fraction decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Femoral arterial stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Karine Miquel</name_or_title>
      <organization>Abbott</organization>
      <phone>+32 479 600 107</phone>
      <email>karine.miquel@abbott.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03227757
org study id: 16-517
nct id: NCT03227757
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid
      Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid
      regurgitation (TR) in patients currently on medical management and who are deemed appropriate
      for percutaneous transcatheter intervention.
This is a prospective, single arm, multi-center study.

      A minimum of 85 subjects will be prospectively enrolled into this single arm study in
      approximately 25 sites, in Europe, Canada and the United States. Patients will be seen for
      follow-up visits at discharge (≤ 7 days post index procedure), 30 days, 6 months, 1,2,3
      years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
time frame: At 30 days
description: Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.
measure: Number of Participants With Composite of Major Adverse Event (MAE)
time frame: At 6 months
description: Major Adverse Event (MAE) is defined as a composite of:
Cardiovascular Mortality
Myocardial Infarction (MI)
Stroke
New onset renal failure
Endocarditis requiring surgery, and
Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure
arm group label: Tricuspid Valve Repair System
arm group type: Experimental
description: Subjects who received TVRS will be included in this arm.
intervention type: Device
intervention name: Tricuspid Valve Repair System
description: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
arm group label: Tricuspid Valve Repair System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Prof. Georg Nickenig
role: Principal Investigator
affiliation: University Hospital, Bonn
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country: France
country: Germany
country: Italy
country: Spain
country: Switzerland
country: United States
responsible party type: Sponsor
mesh term: Tricuspid Valve Insufficiency
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