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/NCT06010563</url>
    </required_header>
    <id_info>
      <org_study_id>VTPR-22-07</org_study_id>
      <nct_id>NCT06010563</nct_id>
    </id_info>
    <brief_title>VenusP-Valve Pivotal Study (PROTEUS STUDY)</brief_title>
    <acronym>PROTEUS</acronym>
    <official_title>Evaluation of the Performance Of The VenusP-ValveTM System in Patients With Native RVOT Dysfunction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Venus MedTech (HangZhou) Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Venus MedTech (HangZhou) 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        A prospective, multi-center, non-randomized interventional study to evaluate the safety and&#xD;
        effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow&#xD;
        tract (RVOT) dysfunction.&#xD;
  &#xD;
        Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12&#xD;
        months, and annually thereafter to 10 years.&#xD;
  &#xD;
        About 60 subjects will be enrolled in this study. Data analysis will be performed after all&#xD;
        enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be&#xD;
        submitted to FDA for PMA approval.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2034</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <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>The rate of procedure or device related mortality at the 30 days follow-up visit post procedure</measure>
      <time_frame>At 30 Days Post Procedure</time_frame>
      <description>Freedom from procedure or device related mortality at 30 days</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure</measure>
      <time_frame>At 6 Months Post Procedure</time_frame>
      <description>Freedom from VenusP-Valve re-intervention and acceptable hemodynamic function at 6 months defined as:&#xD;
  No more than mild regurgitation measured by CMR; AND&#xD;
  Mean RVOT gradient as measured by echocardiography ≤35mmHg.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The rate of all-cause mortality, procedure or device related mortality, and procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years</measure>
      <time_frame>Through Ten Years Post Procedure</time_frame>
      <description>Freedom from all-cause mortality, procedure or device related mortality out to 10 years&#xD;
  Freedom from procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years&#xD;
  MACCE is defined as a non-hierarchic composite including the following procedure or device related events:&#xD;
  1) Stroke 2) RVOT reintervention 3) Arrhythmia 4) Coronary artery compression requiring intervention or causing myocardial infarction 5) Device-related endocarditis 6) Major stent fracture 7) Valve thrombosis 8) Valve embolization or significant malposition 9) Major vascular or access complications* 10) Pulmonary embolism</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of technical Success during the procedure</measure>
      <time_frame>During the Procedure</time_frame>
      <description>Technical success at exit from catheterization lab or operating room&#xD;
  Defined as a composite of:&#xD;
  Freedom from procedure or device related mortality&#xD;
  Successful access, delivery of the device, and retrieval of the delivery system&#xD;
  Correct positioning of the valve(s) into the proper anatomical location&#xD;
  Freedom from reintervention related to the device or to a major vascular or access-related, or cardiac structural complications</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years.</measure>
      <time_frame>At 30 Days, 1-5 Years, 7 Years and 10 Years Post Procedure</time_frame>
      <description>Acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years.&#xD;
  Defined as:&#xD;
  Mean RVOT gradient ≤ 35mmHg AND,&#xD;
  No more than mild regurgitation measured by echocardiography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of procedure success out to 30 days</measure>
      <time_frame>At 30 Days Post Procedure</time_frame>
      <description>Procedure success out to 30 days, defined as follows:&#xD;
  Device success at 30 days.&#xD;
  Defined as a composite of:&#xD;
  Freedom from procedure or device related mortality&#xD;
  Original intended device in place&#xD;
  No additional surgical or interventional procedures related to the procedure or the device since completion of the index procedure&#xD;
  Hemodynamic performance: relief of insufficiency (mild or less pulmonary regurgitation) without producing the opposite (mean RVOT gradient &gt; 35 mmHg) as measured by echocardiography&#xD;
  No new ventricular arrhythmia requiring ICD implantation&#xD;
  None of the following procedure or device related serious adverse events:&#xD;
  Life-threatening major bleeding&#xD;
  Major vascular or cardiac structural complications requiring unplanned reintervention or surgery&#xD;
  Stage 2 or 3 acute kidney injury (AKI) includes new dialysis&#xD;
  Pulmonary embolism&#xD;
  Severe heart failure or hypotension requiring intravenous inotrope</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of valve dysfunction out to 10 years</measure>
      <time_frame>Through Ten Years Post Procedure</time_frame>
      <description>Freedom from valve dysfunction out to 10 years&#xD;
  Defined as a composite of:&#xD;
  RVOT re-intervention for device-related reasons&#xD;
  Hemodynamic dysfunction of the valve (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient &gt; 35 mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>New York Heart Association (NYHA) classification Through out to 10 years</measure>
      <time_frame>Through Ten Years Post Procedure</time_frame>
      <description>Functional status (New York Heart Association (NYHA) classification) out to 10 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characterization of quality-of-life scores out to 5 year, and at 10 years</measure>
      <time_frame>Through Five Years Post Procedure, and at 10 Years Post Procedure</time_frame>
      <description>Characterization of quality-of-life scores out to 5 year, and at 10 years As assessed by the SF-36-QOL.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Pulmonary Regurgitation</condition>
    <arm_group>
      <arm_group_label>TPVI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcatheter pulmonary valve implantation (TPVI)</intervention_name>
      <description>A valve is implanted through a catheter (a narrow tube) and inserted through the femoral vein into the right atrium, right ventricle and pulmonary artery. After careful positioning, the valve is implanted by inflating a set of a balloons on the delivery catheter or self-expanding. After the catheter has been removed, the incision is closed with stitches, which are removed after the area has healed.</description>
      <arm_group_label>TPVI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>VenusP-ValveTM System</intervention_name>
      <description>VenusP-ValveTM System consists of two components:&#xD;
  Transcatheter Pulmonary Valve (TPV)&#xD;
  Delivery System (DS) including Delivery Catheter System (DCS) and Compression Loading System (CLS) The TPV consists of a self-expanding nitinol stent with a single layer tri-leaflet porcine pericardium tissue.&#xD;
  For the Delivery Catheter System (DCS) , the distal (deployment) end of the system features an atraumatic, radiopaque tip. A protective sheath (capsule) covers and maintains the TPV in a crimped position. The handle at the proximal end of the catheter is used to load and deploy the TPV.&#xD;
  The CLS compresses the TPV into the catheter, which including capture tube, valve protection tube, tip support tube, loading mandrels and crimper.</description>
      <arm_group_label>TPVI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Weight ≥25kg (55 lbs.)&#xD;
  &#xD;
            2. Age ≥ 12 years olds&#xD;
  &#xD;
            3. Patients have a dysfunctional native RVOT with severe pulmonary regurgitation (i.e.,&#xD;
               severe pulmonary regurgitation as determined by echocardiography or pulmonary&#xD;
               regurgitant fraction ≥30% as determined by cardiac magnetic resonance imaging) and&#xD;
               without significant pulmonary stenosis (significant pulmonary stenosis is defined as&#xD;
               gradient more than 25mmHg) and are clinically indicated for intervention:&#xD;
  &#xD;
          1) For symptomatic patients, fitting the following criteria:&#xD;
  &#xD;
            -  Severe pulmonary regurgitation measured by echocardiogram or pulmonary regurgitant&#xD;
               fraction ≥30% measured by CMR 2) For asymptomatic patients, including any 2 of the&#xD;
               following criteria:&#xD;
  &#xD;
            -  Mild or moderate RV or LV systolic dysfunction.&#xD;
  &#xD;
            -  Severe RV dilation (RVEDVI ≥145 mL/m2 or RVESVI ≥ 75 mL/m2or RVEDV &gt;2 × LVEDV).&#xD;
  &#xD;
            -  Progressive reduction in objective exercise tolerance. 4. Patient is willing to&#xD;
               consent to participate in the study and will commit to completion of all follow-up&#xD;
               requirements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Clinical or biological signs of infection including active endocarditis.&#xD;
  &#xD;
            2. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.&#xD;
  &#xD;
            3. Leukopenia, anemia, thrombocytopenia, or any known blood clotting disorder, deemed&#xD;
               clinically significant after consultation with Haemato-oncology specialists.&#xD;
  &#xD;
            4. Inappropriate anatomy for femoral or right internal jugular vein (RIJ) introduction&#xD;
               and delivery of the VenusP-ValveTM System.&#xD;
  &#xD;
            5. RVOT anatomy or morphology that is unfavorable for device anchoring.&#xD;
  &#xD;
            6. Anatomy unable to accommodate VenusP-Valve delivery system.&#xD;
  &#xD;
            7. Angiographic evidence of coronary artery compression that would result from&#xD;
               transcatheter pulmonary valve replacement (TPVR).&#xD;
  &#xD;
            8. Emergency interventional/surgical procedures within 30 days prior to the index&#xD;
               procedure.&#xD;
  &#xD;
            9. Planned significant and relevant concomitant procedure at time of VenusP-Valve&#xD;
               implant.&#xD;
  &#xD;
           10. Any planned interventional/surgical procedures to be performed within the 30 days&#xD;
               follow-up from VenusP-Valve implant.&#xD;
  &#xD;
           11. Known history of intravenous drug abuse in the past 5 years, without certificate of&#xD;
               completion of rehabilitation from a specialist.&#xD;
  &#xD;
           12. Major or progressive non-cardiac disease resulting in a life expectancy of less than&#xD;
               one year.&#xD;
  &#xD;
           13. Known hypersensitivity or contraindication to antiplatelet, antithrombotic&#xD;
               medications, or nitinol (titanium or nickel) leading to be unable to undergo index&#xD;
               procedure per physicians' judgement&#xD;
  &#xD;
           14. Positive pregnancy test at baseline (prior to CT angiography and again prior to&#xD;
               implant procedure) in female patients of child-bearing potential.&#xD;
  &#xD;
           15. Currently participating in an investigational drug or another device study.&#xD;
  &#xD;
           16. Patient or guardian unwilling or unable to provide written informed consent or comply&#xD;
               with follow-up requirements.&#xD;
  &#xD;
           17. The investigators consider that the patients are not suitable to participate in this&#xD;
               research.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Cong Ma</last_name>
      <phone>+8618817939751</phone>
      <email>macong@venusmedtech.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 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>Pulmonary 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/NCT06010563
  org study id: VTPR-22-07
  nct id: NCT06010563
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  A prospective, multi-center, non-randomized interventional study to evaluate the safety and
        effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow
        tract (RVOT) dysfunction.
  
        Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12
        months, and annually thereafter to 10 years.
  
        About 60 subjects will be enrolled in this study. Data analysis will be performed after all
        enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be
        submitted to FDA for PMA approval.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The rate of procedure or device related mortality at the 30 days follow-up visit post procedure
  time frame: At 30 Days Post Procedure
  description: Freedom from procedure or device related mortality at 30 days
  measure: The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure
  time frame: At 6 Months Post Procedure
  description: Freedom from VenusP-Valve re-intervention and acceptable hemodynamic function at 6 months defined as:
  No more than mild regurgitation measured by CMR; AND
  Mean RVOT gradient as measured by echocardiography ≤35mmHg.
  measure: The rate of all-cause mortality, procedure or device related mortality, and procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years
  time frame: Through Ten Years Post Procedure
  description: Freedom from all-cause mortality, procedure or device related mortality out to 10 years
  Freedom from procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years
  MACCE is defined as a non-hierarchic composite including the following procedure or device related events:
  1) Stroke 2) RVOT reintervention 3) Arrhythmia 4) Coronary artery compression requiring intervention or causing myocardial infarction 5) Device-related endocarditis 6) Major stent fracture 7) Valve thrombosis 8) Valve embolization or significant malposition 9) Major vascular or access complications* 10) Pulmonary embolism
  measure: The rate of technical Success during the procedure
  time frame: During the Procedure
  description: Technical success at exit from catheterization lab or operating room
  Defined as a composite of:
  Freedom from procedure or device related mortality
  Successful access, delivery of the device, and retrieval of the delivery system
  Correct positioning of the valve(s) into the proper anatomical location
  Freedom from reintervention related to the device or to a major vascular or access-related, or cardiac structural complications
  measure: The rate of acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years.
  time frame: At 30 Days, 1-5 Years, 7 Years and 10 Years Post Procedure
  description: Acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years.
  Defined as:
  Mean RVOT gradient ≤ 35mmHg AND,
  No more than mild regurgitation measured by echocardiography
  measure: The rate of procedure success out to 30 days
  time frame: At 30 Days Post Procedure
  description: Procedure success out to 30 days, defined as follows:
  Device success at 30 days.
  Defined as a composite of:
  Freedom from procedure or device related mortality
  Original intended device in place
  No additional surgical or interventional procedures related to the procedure or the device since completion of the index procedure
  Hemodynamic performance: relief of insufficiency (mild or less pulmonary regurgitation) without producing the opposite (mean RVOT gradient > 35 mmHg) as measured by echocardiography
  No new ventricular arrhythmia requiring ICD implantation
  None of the following procedure or device related serious adverse events:
  Life-threatening major bleeding
  Major vascular or cardiac structural complications requiring unplanned reintervention or surgery
  Stage 2 or 3 acute kidney injury (AKI) includes new dialysis
  Pulmonary embolism
  Severe heart failure or hypotension requiring intravenous inotrope
  measure: The rate of valve dysfunction out to 10 years
  time frame: Through Ten Years Post Procedure
  description: Freedom from valve dysfunction out to 10 years
  Defined as a composite of:
  RVOT re-intervention for device-related reasons
  Hemodynamic dysfunction of the valve (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient > 35 mmHg)
  measure: New York Heart Association (NYHA) classification Through out to 10 years
  time frame: Through Ten Years Post Procedure
  description: Functional status (New York Heart Association (NYHA) classification) out to 10 years
  measure: Characterization of quality-of-life scores out to 5 year, and at 10 years
  time frame: Through Five Years Post Procedure, and at 10 Years Post Procedure
  description: Characterization of quality-of-life scores out to 5 year, and at 10 years As assessed by the SF-36-QOL.
  arm group label: TPVI
  arm group type: Experimental
  intervention type: Device
  intervention name: Transcatheter pulmonary valve implantation (TPVI)
  description: A valve is implanted through a catheter (a narrow tube) and inserted through the femoral vein into the right atrium, right ventricle and pulmonary artery. After careful positioning, the valve is implanted by inflating a set of a balloons on the delivery catheter or self-expanding. After the catheter has been removed, the incision is closed with stitches, which are removed after the area has healed.
  arm group label: TPVI
  intervention type: Device
  intervention name: VenusP-ValveTM System
  description: VenusP-ValveTM System consists of two components:
  Transcatheter Pulmonary Valve (TPV)
  Delivery System (DS) including Delivery Catheter System (DCS) and Compression Loading System (CLS) The TPV consists of a self-expanding nitinol stent with a single layer tri-leaflet porcine pericardium tissue.
  For the Delivery Catheter System (DCS) , the distal (deployment) end of the system features an atraumatic, radiopaque tip. A protective sheath (capsule) covers and maintains the TPV in a crimped position. The handle at the proximal end of the catheter is used to load and deploy the TPV.
  The CLS compresses the TPV into the catheter, which including capture tube, valve protection tube, tip support tube, loading mandrels and crimper.
  arm group label: TPVI
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Cong Ma
  phone: +8618817939751
  email: macong@venusmedtech.com
  responsible party type: Sponsor
  mesh term: Pulmonary Valve Insufficiency
  sharing ipd: No