<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/NCT03294200</url>
  </required_header>
  <id_info>
    <org_study_id>CIP 2101-01</org_study_id>
    <nct_id>NCT03294200</nct_id>
  </id_info>
  <brief_title>Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System</brief_title>
  <official_title>Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>4Tech Cardio Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>4Tech Cardio Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to generate safety and performance data for the 4Tech TriCinch&#xD;
      Coil System in symptomatic patients suffering from significant functional tricuspid&#xD;
      regurgitation with annular dilatation.&#xD;
&#xD;
      The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve&#xD;
      repair.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    As per sponsor&#xD;
  </why_stopped>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">July 14, 2020</completion_date>
  <primary_completion_date type="Actual">July 14, 2020</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>All-cause mortality of the Per Protocol cohort at 30 days post procedure.</measure>
    <time_frame>30 days post procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of individual adverse events related to the system or procedure.</measure>
    <time_frame>30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic changes compared to Baseline by means of echocardiographic semi-quantitative and quantitative measures</measure>
    <time_frame>30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional changes as compared to Baseline for New York Heart Association (NYHA) classification</measure>
    <time_frame>30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent</measure>
    <time_frame>30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise tolerance (Six Minute Walk Test)</measure>
    <time_frame>30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life evaluation (Kansas City Cardiomyopathy Questionnaire).</measure>
    <time_frame>30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Tricuspid Regurgitation</condition>
  <arm_group>
    <arm_group_label>Tricinch Coil System treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TriCinch Coil System implantation</intervention_name>
    <description>Patients enrolled in this study with all eligibility criteria confirmed will be implanted with the TriCinch Coil System. This device offers a percutaneous treatment (access through the vein at the groin) to treat the leaking tricuspid valve, without the need for surgical intervention.</description>
    <arm_group_label>Tricinch Coil System treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Moderate to severe functional tricuspid regurgitation (TR) defined as: TR severity 2+&#xD;
             to 4+ (according to semi-quantitative echocardiographic color flow doppler&#xD;
             evaluation); and Annular diameter ≥ 40 mm confirmed by echocardiography&#xD;
&#xD;
          2. ≥ 18 years old&#xD;
&#xD;
          3. Subject has read and signed the informed consent prior to study related procedures.&#xD;
&#xD;
          4. Willing and able to comply with all required follow-up evaluations and assessments.&#xD;
&#xD;
          5. The 'Heart Team' assessment recommends TriCinch Coil Implantation&#xD;
&#xD;
          6. New York Heart Associate Classification ≥ II.&#xD;
&#xD;
          7. Left Ventricular Ejection Fraction ≥ 30%.&#xD;
&#xD;
          8. Heart failure symptoms (such as fluid retention and severe oedema, liver stasis)&#xD;
             despite on optimized medical therapy by the local heart team; at minimum subject on&#xD;
             diuretic use&#xD;
&#xD;
          9. Subject has suitable anatomy for investigational device implantation as per imaging&#xD;
             requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently participating in another investigational drug or device study.&#xD;
&#xD;
          2. Subject with Systolic pulmonary arterial pressure (sPAP) &gt; 60mmHg as measured by&#xD;
             Transthoracic Echocardiography (TTE)&#xD;
&#xD;
          3. Subject requiring another cardiac procedure in the framework of the index procedure;&#xD;
             subject requiring a percutaneous procedure within 30 days before or after the&#xD;
             procedure or a cardiac surgical procedure within 3 months before or after the&#xD;
             procedure&#xD;
&#xD;
          4. Moderate or Severe tricuspid valve stenosis (defined as a mean gradient ≥5 mmHg at&#xD;
             normal heart rate)&#xD;
&#xD;
          5. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than or equal&#xD;
             to moderate&#xD;
&#xD;
          6. Mitral valve stenosis and/or regurgitation more than moderate&#xD;
&#xD;
          7. Intra-cardiac thrombus, mass or vegetation requiring active treatment.&#xD;
&#xD;
          8. Implanted inferior vena cava (IVC) filter.&#xD;
&#xD;
          9. Prior tricuspid repair or tricuspid replacement&#xD;
&#xD;
         10. Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that&#xD;
             cannot be adequately pre-medicated&#xD;
&#xD;
         11. History of cardiac transplantation&#xD;
&#xD;
         12. Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE).&#xD;
&#xD;
         13. Endocarditis or severe infection within 12 months of scheduled implant procedure&#xD;
&#xD;
         14. Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the&#xD;
             index procedure&#xD;
&#xD;
         15. Cerebro Vascular Accident within the previous 6 months&#xD;
&#xD;
         16. Hemodynamic instability or on IV inotropes&#xD;
&#xD;
         17. Contraindication to anticoagulant therapy and antiplatelet therapy&#xD;
&#xD;
         18. Bleeding disorders or hypercoagulable condition (at risk of blood clots)&#xD;
&#xD;
         19. Active peptic ulcer or active GI bleeding within 3 months of scheduled implant&#xD;
             procedure&#xD;
&#xD;
         20. Severe renal impairment or on dialysis&#xD;
&#xD;
         21. Life expectancy less than 12 months.&#xD;
&#xD;
         22. Acute anemia&#xD;
&#xD;
         23. Chronic Oral Steroid Use ≥ 6 months&#xD;
&#xD;
         24. Pregnant or lactating female of childbearing potential with a positive pregnancy test&#xD;
             24 hours before any study-related radiation exposure&#xD;
&#xD;
         25. Pulmonary embolism within the last 6 months&#xD;
&#xD;
         26. Tricuspid Valve Tethering distance &gt; 10 mm&#xD;
&#xD;
         27. Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as&#xD;
             immobile or interfering with the procedure, as evaluated by echocardiography.&#xD;
&#xD;
         28. Contra-indicated for blood transfusion or refuses transfusion&#xD;
&#xD;
         29. Patient undergoing emergency treatment&#xD;
&#xD;
         30. Patient without appropriate venous access&#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>St Vincent's Hospital</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Heart</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Jan Brugge-Oostende AV</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CardioVascular Center Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Antonius Hospital</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brighton &amp; Sussex University Hospitals - Sussex County Hospital</name>
      <address>
        <city>Brighton</city>
        <zip>BN2 5BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds General Infirmary</name>
      <address>
        <city>Leeds</city>
        <zip>LS1 3EX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX9 3DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</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>Undecided</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/NCT03294200
org study id: CIP 2101-01
nct id: NCT03294200
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to generate safety and performance data for the 4Tech TriCinch
      Coil System in symptomatic patients suffering from significant functional tricuspid
      regurgitation with annular dilatation.

      The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve
      repair.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause mortality of the Per Protocol cohort at 30 days post procedure.
time frame: 30 days post procedure
measure: Number of individual adverse events related to the system or procedure.
time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
measure: Echocardiographic changes compared to Baseline by means of echocardiographic semi-quantitative and quantitative measures
time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
measure: Functional changes as compared to Baseline for New York Heart Association (NYHA) classification
time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
measure: Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent
time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
measure: Exercise tolerance (Six Minute Walk Test)
time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
measure: Quality of Life evaluation (Kansas City Cardiomyopathy Questionnaire).
time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
arm group label: Tricinch Coil System treatment
arm group type: Experimental
intervention type: Device
intervention name: TriCinch Coil System implantation
description: Patients enrolled in this study with all eligibility criteria confirmed will be implanted with the TriCinch Coil System. This device offers a percutaneous treatment (access through the vein at the groin) to treat the leaking tricuspid valve, without the need for surgical intervention.
arm group label: Tricinch Coil System treatment
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: 
country: Australia
country: Belgium
country: Denmark
country: France
country: Germany
country: Netherlands
country: United Kingdom
responsible party type: Sponsor
mesh term: Tricuspid Valve Insufficiency
sharing ipd: Undecided