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/NCT06038838</url>
    </required_header>
    <id_info>
      <org_study_id>CP-03218</org_study_id>
      <nct_id>NCT06038838</nct_id>
    </id_info>
    <brief_title>Feasibility Study of the Tioga TMVR System</brief_title>
    <official_title>Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tioga Cardiovascular, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tioga Cardiovascular, Inc.</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating&#xD;
        patients with symptomatic MR (MR&gt;=3+)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Tioga TMVR Feasibility Study is a prospective, single-arm, multi-center study with a&#xD;
        planned enrollment of up to 30 patients. The Tioga TMVR System is designed to percutaneously&#xD;
        replace a patient's diseased native mitral valve with a bioprosthetic valve. The&#xD;
        investigational device is intended for transseptal replacement of the mitral valve in&#xD;
        patients with symptomatic MR (MR&gt;=3+).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</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>Primary Safety Endpoint</measure>
      <time_frame>From index procedure (Day 0) to 30 days post-procedure</time_frame>
      <description>Number of subjects with all-cause mortality, cardiovascular-related hospitalizations, disabling stroke, and/or mitral valve reintervention or reoperation through 30 days post-procedure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Primary Performance Endpoint</measure>
      <time_frame>At completion of index procedure (Day 0)</time_frame>
      <description>Number of subjects achieving MVARC technical success - all of the following must be present at exit of catheterization lab:&#xD;
  Absence of procedural mortality&#xD;
  Successful access, delivery, and retrieval of the device delivery system&#xD;
  Successful deployment and correct positioning of the first intended device&#xD;
  Freedom from emergency surgery or reintervention related to the device or access procedure</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Mitral Regurgitation</condition>
    <arm_group>
      <arm_group_label>Patients with Symptomatic MR (MR&gt;=3+)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects treated with the Tioga TMVR System</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Tioga TMVR System</intervention_name>
      <description>A bioprosthetic mitral valve, as part of the Tioga TMVR System, is implanted percutaneously in a patient with MR via transfemoral-transseptal access.</description>
      <arm_group_label>Patients with Symptomatic MR (MR&gt;=3+)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 years or older&#xD;
  &#xD;
            -  Symptomatic, moderate to severe (3+) or severe (4+) MR&#xD;
  &#xD;
            -  NYHA Functional Classification ≥ II&#xD;
  &#xD;
            -  Heart team concurs that TMVR is the preferred treatment over surgical intervention or&#xD;
               other available treatment options (e.g., TEER)&#xD;
  &#xD;
            -  The subject or the subject's legal representative has been informed of the nature of&#xD;
               the study, has agreed to return for post-procedure follow-up visits, and has provided&#xD;
               informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  LVEF &lt; 25%&#xD;
  &#xD;
            -  LVEDD &gt; 70 mm&#xD;
  &#xD;
            -  Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and&#xD;
               transseptal access, MAC) unsuitable for the Tioga TMVR System&#xD;
  &#xD;
            -  Severe aortic valve stenosis or regurgitation&#xD;
  &#xD;
            -  Severe right ventricular dysfunction or severe tricuspid valve disease&#xD;
  &#xD;
            -  Evidence of intracardiac thrombus, vegetation, or mass&#xD;
  &#xD;
            -  Prior mitral valve intervention&#xD;
  &#xD;
            -  Prior prosthetic heart valve in any position&#xD;
  &#xD;
            -  Any percutaneous coronary, carotid, or other endovascular intervention within 30 days&#xD;
               prior to enrollment&#xD;
  &#xD;
            -  Any carotid surgery within 30 days prior to enrollment&#xD;
  &#xD;
            -  Any open cardiac or vascular surgery (other than carotid surgery) within 90 days prior&#xD;
               to enrolment&#xD;
  &#xD;
            -  Myocardial infarction within 30 days prior to enrollment&#xD;
  &#xD;
            -  Cardiac resynchronization therapy (CRT) device implanted within 30 days of enrollment&#xD;
  &#xD;
            -  History of endocarditis within 6 months prior to enrollment or evidence of active&#xD;
               systemic infection or sepsis.&#xD;
  &#xD;
            -  Planned cardiovascular procedure within 30 days of enrolment&#xD;
  &#xD;
            -  Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 30 days of&#xD;
               enrollment&#xD;
  &#xD;
            -  Active peptic ulcer or active GI bleeding within 90 days of enrollment&#xD;
  &#xD;
            -  Cardiogenic shock or hemodynamic instability requiring inotropic support or mechanical&#xD;
               heart assistance&#xD;
  &#xD;
            -  Pulmonary arterial hypertension with fixed PASP &gt; 70mmHg or PVR &gt; 5WU that cannot be&#xD;
               reduced to less than 5WU with vasodilator therapy&#xD;
  &#xD;
            -  Severe chronic obstructive pulmonary Disease (COPD) or airways disease requiring&#xD;
               continuous home oxygen&#xD;
  &#xD;
            -  Renal insufficiency (eGFR &lt;20 mL/min) or ESRD on dialysis&#xD;
  &#xD;
            -  Life expectancy &lt; 12 months&#xD;
  &#xD;
            -  Subject is on the waiting list for a transplant or has had a prior heart transplant&#xD;
  &#xD;
            -  Child class C cirrhosis&#xD;
  &#xD;
            -  Blood dycrasias as defined by acute anemia with Hb &lt; 9, platelets &lt; 75K, WBC &lt; 0.5&#xD;
  &#xD;
            -  Female subjects who is breast feeding or pregnant or planning to become pregnant&#xD;
               within the study period.&#xD;
  &#xD;
            -  Known hypersensitivity or contraindication to procedural, post procedural medication&#xD;
               (e.g., contrast solution) or hypersensitivity to nickel or titanium&#xD;
  &#xD;
            -  Inability to tolerate anticoagulation or antiplatelet therapies&#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>Andrew Fu</last_name>
      <phone>(408) 560-2500</phone>
      <email>andrew.fu@tiogamed.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Louisa Wright</last_name>
      <phone>(408) 560-2500</phone>
      <email>louisa@tiogamed.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 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>Mitral Valve Insufficiency</mesh_term>
    </condition_browse>
    <!-- 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/NCT06038838
  org study id: CP-03218
  nct id: NCT06038838
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: Yes
  The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating
        patients with symptomatic MR (MR>=3+)
  The Tioga TMVR Feasibility Study is a prospective, single-arm, multi-center study with a
        planned enrollment of up to 30 patients. The Tioga TMVR System is designed to percutaneously
        replace a patient's diseased native mitral valve with a bioprosthetic valve. The
        investigational device is intended for transseptal replacement of the mitral valve in
        patients with symptomatic MR (MR>=3+).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Primary Safety Endpoint
  time frame: From index procedure (Day 0) to 30 days post-procedure
  description: Number of subjects with all-cause mortality, cardiovascular-related hospitalizations, disabling stroke, and/or mitral valve reintervention or reoperation through 30 days post-procedure
  measure: Primary Performance Endpoint
  time frame: At completion of index procedure (Day 0)
  description: Number of subjects achieving MVARC technical success - all of the following must be present at exit of catheterization lab:
  Absence of procedural mortality
  Successful access, delivery, and retrieval of the device delivery system
  Successful deployment and correct positioning of the first intended device
  Freedom from emergency surgery or reintervention related to the device or access procedure
  arm group label: Patients with Symptomatic MR (MR>=3+)
  arm group type: Experimental
  description: Subjects treated with the Tioga TMVR System
  intervention type: Device
  intervention name: Tioga TMVR System
  description: A bioprosthetic mitral valve, as part of the Tioga TMVR System, is implanted percutaneously in a patient with MR via transfemoral-transseptal access.
  arm group label: Patients with Symptomatic MR (MR>=3+)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Andrew Fu
  phone: (408) 560-2500
  email: andrew.fu@tiogamed.com
  last name: Louisa Wright
  phone: (408) 560-2500
  email: louisa@tiogamed.com
  responsible party type: Sponsor
  mesh term: Mitral Valve Insufficiency