<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/NCT04433065</url>
  </required_header>
  <id_info>
    <org_study_id>MDT20009TMV003</org_study_id>
    <nct_id>NCT04433065</nct_id>
  </id_info>
  <brief_title>TTVR Early Feasibility Study</brief_title>
  <official_title>The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Cardiovascular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiovascular</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 objective of this early feasibility study is to gain early clinical insight into the&#xD;
      performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended&#xD;
      for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid&#xD;
      valve.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multi-center, prospective, non-randomized, investigational, and pre-market.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 20, 2020</start_date>
  <completion_date type="Anticipated">November 15, 2026</completion_date>
  <primary_completion_date type="Anticipated">August 28, 2023</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>Rate of implant or delivery related serious adverse events</measure>
    <time_frame>Through 30 days post-procedure</time_frame>
    <description>Rate of implant or delivery related serious adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)</measure>
    <time_frame>During Procedure</time_frame>
    <description>For procedural success to be present, device success must have been achieved without major clinical complications as detailed per clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement (part 2: endpoint definitions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TR Grade from baseline</measure>
    <time_frame>Through 30 days post-procedure</time_frame>
    <description>Change in TR Grade from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of no significant TV stenosis</measure>
    <time_frame>Through 30 days post-procedure</time_frame>
    <description>Rate of no significant TV stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NYHA Class from baseline</measure>
    <time_frame>Through 30 days post-procedure</time_frame>
    <description>Change in NYHA Class from baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Tricuspid Regurgitation</condition>
  <arm_group>
    <arm_group_label>Primary Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: Intrepid TTVR System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intrepid™ TTVR System</intervention_name>
    <description>Device: Intrepid™ TTVR System</description>
    <arm_group_label>Primary Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Heart Team agrees that patient is deemed symptomatic despite medical therapy&#xD;
             (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve&#xD;
             replacement&#xD;
&#xD;
          -  Subject is at an intermediate or greater estimated risk of mortality with tricuspid&#xD;
             valve surgery as determined by the local Heart Team&#xD;
&#xD;
          -  Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation&#xD;
             determined by the Echocardiography Core Lab assessment of a qualifying transthoracic&#xD;
             echocardiogram (TTE) and transesophageal echocardiogram (TEE)&#xD;
&#xD;
          -  New York Heart Association (NYHA) Function Class II or greater&#xD;
&#xD;
          -  Subject anatomically suitable for the Intrepid TTVR delivery system including&#xD;
             transfemoral access&#xD;
&#xD;
          -  Subject and the treating physician agree that the subject will return for all required&#xD;
             post-procedure follow-up visits&#xD;
&#xD;
          -  Subject meets the legal minimum age to provide informed consent based on local&#xD;
             regulatory requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Estimated life expectancy of less than 24 months due to associated non-cardiac&#xD;
             co-morbid conditions&#xD;
&#xD;
          -  Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)&#xD;
&#xD;
          -  Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus&#xD;
&#xD;
          -  Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter&#xD;
             or congenital abnormalities of the IVC that would preclude ability for transfemoral&#xD;
             access of delivery system&#xD;
&#xD;
          -  Echocardiographic evidence of severe right ventricular dysfunction&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &lt;30 as measured by resting echocardiogram&#xD;
             within 30 days of the Index Procedure&#xD;
&#xD;
          -  Need for emergent or urgent surgery&#xD;
&#xD;
          -  Untreated clinically significant coronary artery disease requiring revascularization&#xD;
&#xD;
          -  Carcinoid tricuspid regurgitation&#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_contact>
    <last_name>Sarah Brown</last_name>
    <phone>7075917775</phone>
    <email>rs.tmvrtransfemoralefs@medtronic.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lynnett Stahl</last_name>
    <email>rs.tmvrtransfemoralefs@medtronic.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alabama at Birmingham (UAB) Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Mustafa Ahmed, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Abrazo Arizona Heart Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Timothy Byrne, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Khaled Alsabaawi</last_name>
      <email>khaled.alsabaawi@cshs.org</email>
    </contact>
    <investigator>
      <last_name>Raj Makkar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Christian Spies, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Adam Greenbaum, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Oakley</last_name>
    </contact>
    <investigator>
      <last_name>Stanley Chetcuti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Paul Sorajja, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Azeem Latib, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center/NYPH</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Susheel Kodali, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>OhioHealth Riverside Methodist Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Steven Yakubov, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Firas Zahr, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Pinnacle Harrisburg Campus</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Hemal Gada, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sachin Goel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora St. Lukes Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53125</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jodi Kresa</last_name>
    </contact>
    <investigator>
      <last_name>Tanvir Bajwa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eric Weiss, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tricuspid Valve Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04433065
org study id: MDT20009TMV003
nct id: NCT04433065
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The objective of this early feasibility study is to gain early clinical insight into the
      performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended
      for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid
      valve.
Multi-center, prospective, non-randomized, investigational, and pre-market.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of implant or delivery related serious adverse events
time frame: Through 30 days post-procedure
description: Rate of implant or delivery related serious adverse events
measure: Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)
time frame: During Procedure
description: For procedural success to be present, device success must have been achieved without major clinical complications as detailed per clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement (part 2: endpoint definitions)
measure: Change in TR Grade from baseline
time frame: Through 30 days post-procedure
description: Change in TR Grade from baseline
measure: Rate of no significant TV stenosis
time frame: Through 30 days post-procedure
description: Rate of no significant TV stenosis
measure: Change in NYHA Class from baseline
time frame: Through 30 days post-procedure
description: Change in NYHA Class from baseline
arm group label: Primary Cohort
arm group type: Experimental
description: Device: Intrepid TTVR System
intervention type: Device
intervention name: Intrepid™ TTVR System
description: Device: Intrepid™ TTVR System
arm group label: Primary Cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah Brown
phone: 7075917775
email: rs.tmvrtransfemoralefs@medtronic.com
last name: Lynnett Stahl
email: rs.tmvrtransfemoralefs@medtronic.com
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Tricuspid Valve Insufficiency
sharing ipd: No