<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/NCT03775759</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00072372</org_study_id>
    <nct_id>NCT03775759</nct_id>
  </id_info>
  <brief_title>Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study</brief_title>
  <acronym>TVVAD</acronym>
  <official_title>Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the utility of tricuspid valve repair at the time&#xD;
      of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation.&#xD;
      The study will be a randomized trial for patients presenting for LVAD implantation to either&#xD;
      tricuspid valve repair or no tricuspid valve repair. The data will be analyzed as both an&#xD;
      intention to treat analysis as well as an &quot;as treated&quot; analysis with the primary outcome&#xD;
      being rates of right ventricular dysfunction post LVAD implantation. Tricuspid valve repair&#xD;
      for these patient is currently being done for some patients, without any strong data to&#xD;
      either support such practice or negate it.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, single center, randomized trial. Up to 280 subjects will be&#xD;
      enrolled.&#xD;
&#xD;
      Inclusion Criteria - Potential subjects must meet all inclusion criteria to participate.&#xD;
&#xD;
        -  Planned LVAD implantation (either destination or bridge indication)&#xD;
&#xD;
        -  18 years of age or older&#xD;
&#xD;
        -  Patients wilith mild tricuspid regurgitation (TR) during surgical planning will be&#xD;
           screened for meeting inclusion criteria for this study.&#xD;
&#xD;
        -  TR on pre-operative echo (within one week of procedure) (TTE or intraoperative TEE)&#xD;
           quantified as moderate or severe with normal tricuspid valve leaflets&#xD;
&#xD;
      Exclusion Criteria&#xD;
&#xD;
        -  Previous tricuspid valve surgery&#xD;
&#xD;
        -  Previous LVAD&#xD;
&#xD;
        -  Planned concurrent right ventricular assist device (RVAD) or extracorporeal membrane&#xD;
           oxygenation (ECMO) at the time of LVAD operation or during the same hospitalization&#xD;
&#xD;
        -  Preimplant RVAD or ECMO&#xD;
&#xD;
        -  Planned thoracotomy approach for LVAD implantation&#xD;
&#xD;
        -  Pregnant women&#xD;
&#xD;
      All subjects will undergo an intraoperative transesophageal echocardiogram (TEE) to evaluate&#xD;
      their tricuspid valve. Subjects will be randomized in the operating room. Randomization will&#xD;
      be stratified based on preoperative right ventricle dysfunction. Subjects will be randomized&#xD;
      1:1 to either of the following treatment arms:&#xD;
&#xD;
        -  Study arm (Arm A) - Tricuspid valve ring annuloplasty or replacement at the time of LVAD&#xD;
           implantation plus medical therapy&#xD;
&#xD;
        -  Control arm (Arm B) - LVAD implantation plus medical therapy (the medical therapy&#xD;
           involved includes inotropic medications and diuretic medications, which are standard of&#xD;
           care for patients in this population)&#xD;
&#xD;
      Subjects will be monitored in the surgical and on the step down floor ICU, and follow-up data&#xD;
      will be collected on subjects monthly from routine tests and clinic visits. This will include&#xD;
      information on adverse events and any hospital readmissions, a quality of life questionnaire&#xD;
      at their 6 and 12 month visit, and a six minute walk test at 3, 6, and 12 months.&#xD;
      Cardiopulmonary exercise testing will be completed at 12 or greater months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2018</start_date>
  <completion_date type="Actual">February 15, 2023</completion_date>
  <primary_completion_date type="Actual">February 15, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled, non-blinded, single center</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively</measure>
    <time_frame>6 months post-operatively</time_frame>
    <description>Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients experiencing moderate or greater right heart failure at 12 months post-operatively</measure>
    <time_frame>12 months post-operatively</time_frame>
    <description>Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Tricuspid Valve Insufficiency</condition>
  <condition>Right Heart Failure</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Study arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>LVAD implantation plus medical therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tricuspid valve repair or replacement</intervention_name>
    <description>Available rings used at Duke include the Tri-Ad™ Adams Tricuspid Ring by Medtronic, the TAILOR™ FLEXIBLE ANNULOPLASTY RING by St. Jude Medical/Abbott, and the Carpentier-Edwards Physio II Ring by Edwards LifeSciences. Available valves used at Duke include the Mosaic™ Mitral Orbutrator by Medtronic, the Carpentier-Edwardes PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis by Edwards LifeSciences, the On-X Mitral Valve, by CryoLife, the Carbomedics Prosthetic Heart Valve by LivaNova, and the St. Jude Medical™ Mechanical Heart Valve by St. Jude Medical/Abbott.</description>
    <arm_group_label>Study arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical management of tricuspid regurgitation</intervention_name>
    <description>The medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population.</description>
    <arm_group_label>Control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Planned LVAD implantation (either destination or bridge indication)&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Patients will mild tricuspid regurgitation (TR) during surgical planning will be&#xD;
             screened for meeting inclusion criteria for this study.&#xD;
&#xD;
          -  Patients with moderate or graeter TR on pre-operative echo (within one week of&#xD;
             procedure) (TTE or intraoperative TEE) will qualify for randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous tricuspid valve surgery&#xD;
&#xD;
          -  Previous left ventricular assist device&#xD;
&#xD;
          -  Planned concurrent right ventricular assist device (RVAD) or extracorporeal membrane&#xD;
             oxygenation (ECMO) at the time of LVAD operation or during the same hospitalization&#xD;
&#xD;
          -  Preimplant RVAD or ECMO&#xD;
&#xD;
          -  Pregnant women&#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>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Mendiola Pla M, Chiang Y, Nicoara A, Poehlein E, Green CL, Gross R, Bryner BS, Schroder JN, Daneshmand MA, Russell SD, DeVore AD, Patel CB, Katz JN, Milano CA, Bishawi M. Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation: Interim analysis of the TVVAD trial. J Thorac Cardiovasc Surg. 2022 Nov 16:S0022-5223(22)01243-0. doi: 10.1016/j.jtcvs.2022.10.054. Online ahead of print.</citation>
    <PMID>36639288</PMID>
  </results_reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Left ventricular assist device</keyword>
  <keyword>Tricuspid regurgitation</keyword>
  <keyword>Right heart failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Tricuspid Valve Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03775759
org study id: Pro00072372
nct id: NCT03775759
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The purpose of this study is to determine the utility of tricuspid valve repair at the time
      of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation.
      The study will be a randomized trial for patients presenting for LVAD implantation to either
      tricuspid valve repair or no tricuspid valve repair. The data will be analyzed as both an
      intention to treat analysis as well as an "as treated" analysis with the primary outcome
      being rates of right ventricular dysfunction post LVAD implantation. Tricuspid valve repair
      for these patient is currently being done for some patients, without any strong data to
      either support such practice or negate it.
This study is a prospective, single center, randomized trial. Up to 280 subjects will be
      enrolled.

      Inclusion Criteria - Potential subjects must meet all inclusion criteria to participate.

        -  Planned LVAD implantation (either destination or bridge indication)

        -  18 years of age or older

        -  Patients wilith mild tricuspid regurgitation (TR) during surgical planning will be
           screened for meeting inclusion criteria for this study.

        -  TR on pre-operative echo (within one week of procedure) (TTE or intraoperative TEE)
           quantified as moderate or severe with normal tricuspid valve leaflets

      Exclusion Criteria

        -  Previous tricuspid valve surgery

        -  Previous LVAD

        -  Planned concurrent right ventricular assist device (RVAD) or extracorporeal membrane
           oxygenation (ECMO) at the time of LVAD operation or during the same hospitalization

        -  Preimplant RVAD or ECMO

        -  Planned thoracotomy approach for LVAD implantation

        -  Pregnant women

      All subjects will undergo an intraoperative transesophageal echocardiogram (TEE) to evaluate
      their tricuspid valve. Subjects will be randomized in the operating room. Randomization will
      be stratified based on preoperative right ventricle dysfunction. Subjects will be randomized
      1:1 to either of the following treatment arms:

        -  Study arm (Arm A) - Tricuspid valve ring annuloplasty or replacement at the time of LVAD
           implantation plus medical therapy

        -  Control arm (Arm B) - LVAD implantation plus medical therapy (the medical therapy
           involved includes inotropic medications and diuretic medications, which are standard of
           care for patients in this population)

      Subjects will be monitored in the surgical and on the step down floor ICU, and follow-up data
      will be collected on subjects monthly from routine tests and clinic visits. This will include
      information on adverse events and any hospital readmissions, a quality of life questionnaire
      at their 6 and 12 month visit, and a six minute walk test at 3, 6, and 12 months.
      Cardiopulmonary exercise testing will be completed at 12 or greater months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled, non-blinded, single center
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively
time frame: 6 months post-operatively
description: Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria
measure: Proportion of patients experiencing moderate or greater right heart failure at 12 months post-operatively
time frame: 12 months post-operatively
description: Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria
arm group label: Study arm
arm group type: Experimental
description: Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy
arm group label: Control arm
arm group type: Active Comparator
description: LVAD implantation plus medical therapy
intervention type: Procedure
intervention name: Tricuspid valve repair or replacement
description: Available rings used at Duke include the Tri-Ad™ Adams Tricuspid Ring by Medtronic, the TAILOR™ FLEXIBLE ANNULOPLASTY RING by St. Jude Medical/Abbott, and the Carpentier-Edwards Physio II Ring by Edwards LifeSciences. Available valves used at Duke include the Mosaic™ Mitral Orbutrator by Medtronic, the Carpentier-Edwardes PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis by Edwards LifeSciences, the On-X Mitral Valve, by CryoLife, the Carbomedics Prosthetic Heart Valve by LivaNova, and the St. Jude Medical™ Mechanical Heart Valve by St. Jude Medical/Abbott.
arm group label: Study arm
intervention type: Other
intervention name: Medical management of tricuspid regurgitation
description: The medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population.
arm group label: Control arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Mendiola Pla M, Chiang Y, Nicoara A, Poehlein E, Green CL, Gross R, Bryner BS, Schroder JN, Daneshmand MA, Russell SD, DeVore AD, Patel CB, Katz JN, Milano CA, Bishawi M. Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation: Interim analysis of the TVVAD trial. J Thorac Cardiovasc Surg. 2022 Nov 16:S0022-5223(22)01243-0. doi: 10.1016/j.jtcvs.2022.10.054. Online ahead of print.
PMID: 36639288
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Tricuspid Valve Insufficiency
sharing ipd: No