xml: <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/NCT06033274</url>
    </required_header>
    <id_info>
      <org_study_id>2023-15312</org_study_id>
      <nct_id>NCT06033274</nct_id>
    </id_info>
    <brief_title>Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment</brief_title>
    <acronym>TRIPLACE</acronym>
    <official_title>Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment: the TRIPLACE Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Montefiore Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Toronto</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Hospital, Bordeaux</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Montefiore Medical Center</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on&#xD;
        this topic are scarce. Particularly, little is known about which patients are at greatest&#xD;
        risk of procedural complications, such as the timing and onset of conduction disturbances&#xD;
        necessitating permanent pacemaker implantation, and how such patients are managed. On this&#xD;
        background, the TRIPLACE Registry - an investigator-initiated global multicenter registry -&#xD;
        is aimed at better understanding the safety and efficacy of orthotopic TTVR.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">August 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2026</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Freedom from device-related complications</measure>
      <time_frame>30 days after the index procedure</time_frame>
      <description>Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reduction in Tricuspid Regurgitation Severity</measure>
      <time_frame>30 days after the index procedure</time_frame>
      <description>Tricuspid Regurgitation measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.&#xD;
  Tricuspid Regurgitation is measured by transthoracic echocardiography in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Change from baseline tricuspid regurgitation severity score 30 days after baseline will be assessed</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Permanent Pacemaker Implantation</measure>
      <time_frame>30 days after the index procedure</time_frame>
      <description>The number of participants who have received a permanent pacemaker implantation will be recorded</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Combined all-cause mortality or rehospitalization for congestive heart failure</measure>
      <time_frame>12 months after the index procedure</time_frame>
      <description>The composite of mortality from any cause and participants re-hospitalized for acute decompensated congestive heart failure will be recorded</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause mortality</measure>
      <time_frame>12 months after the index procedure</time_frame>
      <description>The number of deaths due to any cause will be recorded</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospitalization for congestive heart failure</measure>
      <time_frame>12 months after the index procedure</time_frame>
      <description>The number of participants who have been hospitalized with acute decompensated congestive heart failure will be recorded</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of participants with New York Heart Association (NYHA) Stage III or IV heart failure</measure>
      <time_frame>12 months after the index procedure</time_frame>
      <description>The number of participants who meet either NYHA III or NYHA IV classifications for heart failure will be recorded.&#xD;
  NYHA Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest&#xD;
  NYHA Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Device Thrombosis</measure>
      <time_frame>12 months after the index procedure</time_frame>
      <description>The number of participants who have been identified with device thrombosis will be recorded</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tricuspid Regurgitation Severity</measure>
      <time_frame>12 months after the index procedure</time_frame>
      <description>Tricuspid Regurgitation is measured by transthoracic echocardiography. Assessment of MI severity will be conducted in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Higher mean scores are indicative of greater TR severity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life - Kansas City Cardiomyopathy Questionnaire</measure>
      <time_frame>12 months after the index procedure</time_frame>
      <description>Quality of Life is evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ has a 2-week recall period and includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score that mirrors the key concepts of the NYHA functional class. The symptom, physical limitations, social limitations, and quality of life domains are combined to create an overall summary score, which is the primary health status outcome All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tricuspid Valve Reintervention</measure>
      <time_frame>12 months after the index procedure</time_frame>
      <description>The number of participants who undergo tricuspid valve surgical and/or transcatheter reintervention will be summed and recorded</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Tricuspid Regurgitation</condition>
    <arm_group>
      <arm_group_label>Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve Replacement</arm_group_label>
      <description>Patients having clinically significant tricuspid regurgitation, defined according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease, requiring transcatheter tricuspid valve replacement</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcatheter Tricuspid Valve Replacement</intervention_name>
      <description>All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease</description>
      <arm_group_label>Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve Replacement</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing orthotopic Transcatheter Tricuspid Valve Replacement for clinically&#xD;
          significant tricuspid valve disease.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing Transcatheter Tricuspid Valve Replacement&#xD;
  &#xD;
            -  Native Tricuspid Valve disease&#xD;
  &#xD;
            -  Orthotopic Tricuspid Valve Implantation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age under 18 years&#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>Andrea Scotti, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Montefiore Medical Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Azeem Latib, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Montefiore Medical Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Rishi Puri, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Cleveland Clinic</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Neil Fam, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>St. Michaels Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Thomas Modine, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Bordeaux</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andrea Scotti, MD</last_name>
      <phone>7189043388</phone>
      <email>ascotti@montefiore.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rishi Puri, MD</last_name>
      <phone>(216) 444-2273</phone>
      <email>purir@ccf.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Montefiore Medical Center</name>
        <address>
          <city>Bronx</city>
          <state>New York</state>
          <zip>10461</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Andrea Scotti, MD</last_name>
        <phone>718-904-3388</phone>
        <phone_ext>+1</phone_ext>
        <email>ascotti@montefiore.org</email>
      </contact>
      <contact_backup>
        <last_name>Azeem Latib, MD</last_name>
        <phone>718-904-3388</phone>
        <phone_ext>+1</phone_ext>
        <email>mlatib@montefiore.org</email>
      </contact_backup>
      <investigator>
        <last_name>Azeem Latib, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Andrea Scotti, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Cleveland Clinic</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rishi Puri, MD</last_name>
        <phone>216-444-2273</phone>
        <phone_ext>1</phone_ext>
        <email>purir@ccf.org</email>
      </contact>
      <investigator>
        <last_name>Rishi Puri</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>St Thomas Elgin General Hospital</name>
        <address>
          <city>Saint Thomas</city>
          <state>Ontario</state>
          <zip>N5R 5C4</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Neil Fam, MD</last_name>
        <phone>(647) 776-2500</phone>
        <email>Neil.Fam@unityhealth.to</email>
      </contact>
      <investigator>
        <last_name>Neil Fam, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Chu De Bordeaux - Haut-Lévêque Hospital</name>
        <address>
          <city>Bordeaux</city>
          <state>Pessac</state>
          <zip>33600</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Thomas Modine, MD</last_name>
        <phone>556795679</phone>
        <phone_ext>33</phone_ext>
        <email>thomasmodine@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Thomas Modine, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
      <country>France</country>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>valvular heart disease</keyword>
    <keyword>tricuspid regurgitation</keyword>
    <keyword>transcatheter tricuspid valve replacement</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>
  
  
text: 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/NCT06033274
  org study id: 2023-15312
  nct id: NCT06033274
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on
        this topic are scarce. Particularly, little is known about which patients are at greatest
        risk of procedural complications, such as the timing and onset of conduction disturbances
        necessitating permanent pacemaker implantation, and how such patients are managed. On this
        background, the TRIPLACE Registry - an investigator-initiated global multicenter registry -
        is aimed at better understanding the safety and efficacy of orthotopic TTVR.
  observational model: Cohort
  time perspective: Retrospective
  measure: Freedom from device-related complications
  time frame: 30 days after the index procedure
  description: Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications
  measure: Reduction in Tricuspid Regurgitation Severity
  time frame: 30 days after the index procedure
  description: Tricuspid Regurgitation measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.
  Tricuspid Regurgitation is measured by transthoracic echocardiography in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Change from baseline tricuspid regurgitation severity score 30 days after baseline will be assessed
  measure: Permanent Pacemaker Implantation
  time frame: 30 days after the index procedure
  description: The number of participants who have received a permanent pacemaker implantation will be recorded
  measure: Combined all-cause mortality or rehospitalization for congestive heart failure
  time frame: 12 months after the index procedure
  description: The composite of mortality from any cause and participants re-hospitalized for acute decompensated congestive heart failure will be recorded
  measure: All-cause mortality
  time frame: 12 months after the index procedure
  description: The number of deaths due to any cause will be recorded
  measure: Hospitalization for congestive heart failure
  time frame: 12 months after the index procedure
  description: The number of participants who have been hospitalized with acute decompensated congestive heart failure will be recorded
  measure: The number of participants with New York Heart Association (NYHA) Stage III or IV heart failure
  time frame: 12 months after the index procedure
  description: The number of participants who meet either NYHA III or NYHA IV classifications for heart failure will be recorded.
  NYHA Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest
  NYHA Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients
  measure: Device Thrombosis
  time frame: 12 months after the index procedure
  description: The number of participants who have been identified with device thrombosis will be recorded
  measure: Tricuspid Regurgitation Severity
  time frame: 12 months after the index procedure
  description: Tricuspid Regurgitation is measured by transthoracic echocardiography. Assessment of MI severity will be conducted in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Higher mean scores are indicative of greater TR severity
  measure: Quality of Life - Kansas City Cardiomyopathy Questionnaire
  time frame: 12 months after the index procedure
  description: Quality of Life is evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ has a 2-week recall period and includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score that mirrors the key concepts of the NYHA functional class. The symptom, physical limitations, social limitations, and quality of life domains are combined to create an overall summary score, which is the primary health status outcome All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life
  measure: Tricuspid Valve Reintervention
  time frame: 12 months after the index procedure
  description: The number of participants who undergo tricuspid valve surgical and/or transcatheter reintervention will be summed and recorded
  arm group label: Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve Replacement
  description: Patients having clinically significant tricuspid regurgitation, defined according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease, requiring transcatheter tricuspid valve replacement
  intervention type: Device
  intervention name: Transcatheter Tricuspid Valve Replacement
  description: All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease
  arm group label: Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve Replacement
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Andrea Scotti, MD
  role: Principal Investigator
  affiliation: Montefiore Medical Center
  last name: Azeem Latib, MD
  role: Principal Investigator
  affiliation: Montefiore Medical Center
  last name: Rishi Puri, MD
  role: Principal Investigator
  affiliation: The Cleveland Clinic
  last name: Neil Fam, MD
  role: Principal Investigator
  affiliation: St. Michaels Hospital
  last name: Thomas Modine, MD
  role: Principal Investigator
  affiliation: University Hospital, Bordeaux
  last name: Andrea Scotti, MD
  phone: 7189043388
  email: ascotti@montefiore.org
  last name: Rishi Puri, MD
  phone: (216) 444-2273
  email: purir@ccf.org
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: Canada
  country: France
  country: United States
  responsible party type: Sponsor
  mesh term: Tricuspid Valve Insufficiency
  sharing ipd: No