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/NCT05991271</url>
    </required_header>
    <id_info>
      <org_study_id>VTAR-23-03</org_study_id>
      <nct_id>NCT05991271</nct_id>
    </id_info>
    <brief_title>Venus-Vitae Pivotal Study Smart-Align Study</brief_title>
    <official_title>Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae&#xD;
        Transcatheter Heart Valve System in patients with severe aortic stenosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This trial is a prospective, multi-center, non-randomized interventional study to evaluate&#xD;
        the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System&#xD;
        in patients with severe aortic stenosis. Clinical visits will be scheduled at screening,&#xD;
        pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2029</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>The rate of deaths at the one-year follow-up visit post procedure</measure>
      <time_frame>1 Years</time_frame>
      <description>All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptable Hemodynamic Performance at 30 days</measure>
      <time_frame>30 Days</time_frame>
      <description>Acceptable Bio-prosthesis Hemodynamic Performance at 30 days, defined as:&#xD;
  Mean gradient &lt; 20mmHg&#xD;
  Less than moderate aortic regurgitation (perivalvular and transvalvular)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Occurrence of the following adverse events echocardiogram during follow-up</measure>
      <time_frame>5 Years</time_frame>
      <description>Occurrence of the following adverse events echocardiogram during follow-up (The rate of follow events during the follow-up)&#xD;
  All-cause mortality&#xD;
  All stroke&#xD;
  Life-threatening bleeding&#xD;
  Acute MI&#xD;
  Heart failure hospitalizations&#xD;
  New permanent pacemaker implantation&#xD;
  Major vascular complication&#xD;
  Acute kidney injury&#xD;
  Aortic valve re-intervention (surgical or transcatheter)&#xD;
  Valve thrombosis&#xD;
  Structural valve deterioration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Technical success is defined as the following</measure>
      <time_frame>During the Procedure</time_frame>
      <description>Technical success (at exit from procedure room) (VARC-3[1]) (The rate of Technical success at the Procedure)&#xD;
  Freedom from mortality&#xD;
  Successful access, delivery of the device, and retrieval of the delivery system&#xD;
  Correct positioning of a single prosthetic heart valve into the proper anatomical location&#xD;
  Freedom from surgery or intervention related to the device or a major vascular or access-related, or cardiac structural complication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of device success is defined as the following</measure>
      <time_frame>Up to 1 week</time_frame>
      <description>Device success (in-hospital) (VARC-3[1]) (The rate of device success during the in-hospital)&#xD;
  Freedom from mortality&#xD;
  Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication&#xD;
  Intended performance of the valve (mean gradient &lt; 20 mmHg, peak velocity &lt;3 m/s, and less than moderate aortic regurgitation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:</measure>
      <time_frame>Up to 1 week</time_frame>
      <description>Acceptable valve function at pre-discharge by echocardiogram (The rate of follow events during the follow-up)&#xD;
  Freedom from moderate or greater patient-prosthesis mismatch (PPM)&#xD;
  MPG &lt;20mmHg&#xD;
  Freedom from moderate or greater regurgitation (transvalvular and paravalvular)&#xD;
  Freedom from reoperation or intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of freedom from severe coronary overlap assessed by post-implant angiogram</measure>
      <time_frame>immediately after the procedure</time_frame>
      <description>Freedom from severe coronary overlap assessed by post-implant angiogram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT</measure>
      <time_frame>30-Days</time_frame>
      <description>Freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT (post-implant 30-day CT scan is not mandatory for each subjects)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of freedom from mild or greater PVL by echocardiogram during follow-up</measure>
      <time_frame>5 Years</time_frame>
      <description>Freedom from mild or greater PVL by echocardiogram during follow-up</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>New York Heart Association (NYHA) classification during follow-up</measure>
      <time_frame>5 Years</time_frame>
      <description>New York Heart Association (NYHA) classification during follow-up</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Aortic Valve Stenosis</condition>
    <arm_group>
      <arm_group_label>procedure</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>implant valve by TAVR</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Venus-Vitae Transcatheter Heart Valve System</intervention_name>
      <description>The Venus-Vitae THV is comprised of balloon-expandable and radiopaque cobalt-chromium alloy frame, porcine pericardium tri-leaflet, porcine pericardium inner skirt, polyurethane outer skirt, PTFE assembly sutures, and three radiopaque gold markers (Figure 1). The valve utilizes Venus Endura technology and stored in a non-aqueous condition.</description>
      <arm_group_label>procedure</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years&#xD;
  &#xD;
            2. Patients with the symptoms of severe aortic stenosis&#xD;
  &#xD;
            3. Severe aortic stenosis (AS, grade 3+), defined as AVA ≤ 1 cm2 (AVAi ≤ 0.6 cm2/m3) or&#xD;
               Vmax ≥ 4.0 m/s or MPG ≥ 40 mmHg determined by echocardiography&#xD;
  &#xD;
            4. Patients deemed for cardiac intervention by a heart team&#xD;
  &#xD;
            5. Patients of all surgical risk categories can be enrolled in this study, but should&#xD;
               follows local medical practices and regulatories.&#xD;
  &#xD;
            6. Patients or their legal reprensentatives are willing to participate in the study and&#xD;
               provide written informed consent, and agree to follow the follow-up requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          A subject meeting any of the following criteria shall be excluded:&#xD;
  &#xD;
          Co-morbidities&#xD;
  &#xD;
            1. Previous mechanical or biological aortic valve replacement&#xD;
  &#xD;
            2. Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural&#xD;
               intervention&#xD;
  &#xD;
            3. Acute myocardial infact within 30 days prior to index procedure&#xD;
  &#xD;
            4. Untreated clinical significant coronary artery disease requiring revascularization&#xD;
  &#xD;
            5. Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting&#xD;
               coronary stent/scaffold implant within 6 months)&#xD;
  &#xD;
            6. Sever symptomatic carotid artery stenosis&#xD;
  &#xD;
            7. Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability&#xD;
  &#xD;
            8. Chronic kidney disease (eGFR&lt;30 mL/min/1.73m2)&#xD;
  &#xD;
            9. Haemotologic disorders: Leukopenia (WBC &lt; 3000 cell/mL), anemia (Hgb &lt; 9 g/dL),&#xD;
               thrombocytopenia (Plt&lt; 50,000 cell/mL), or any known blood clotting disorder, deemed&#xD;
               clinically significant after consultation with Haematooncology specialists&#xD;
  &#xD;
           10. Severe right heart dysfunction Anatomical&#xD;
  &#xD;
           11. LVEF &lt; 20%&#xD;
  &#xD;
           12. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation&#xD;
  &#xD;
           13. Inappropriate anatomy for femoral introduction and delivery of study device&#xD;
  &#xD;
           14. Native aortic valve geometry and size unfavorable for study device anchoring General&#xD;
  &#xD;
           15. Haemodynamics instability requiring inotropic support or intra-aortic balloon pump&#xD;
               (IABP) or other hemodynamic support device, or any mechanical heart assistance&#xD;
  &#xD;
           16. Known hypersensitivity or contraindication to antiplatelet, antithrombotic&#xD;
               medications, or cobalt-chromium leading to be unable to undergo index procedure per&#xD;
               physicians' judgement&#xD;
  &#xD;
           17. Life expectancy ≤ 1 year due to noncardiac reasons&#xD;
  &#xD;
           18. Active infection requiring antibiotic therapy including infective endocarditis&#xD;
  &#xD;
           19. Planned relevant concomitant procedure within 30 days post index procedure&#xD;
  &#xD;
           20. Pregnant, breastfeeding or intend to become pregnant within 1 year&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 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>Aortic Valve Stenosis</mesh_term>
      <mesh_term>Constriction, Pathologic</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/NCT05991271
  org study id: VTAR-23-03
  nct id: NCT05991271
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae
        Transcatheter Heart Valve System in patients with severe aortic stenosis.
  This trial is a prospective, multi-center, non-randomized interventional study to evaluate
        the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System
        in patients with severe aortic stenosis. Clinical visits will be scheduled at screening,
        pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The rate of deaths at the one-year follow-up visit post procedure
  time frame: 1 Years
  description: All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)
  measure: Acceptable Hemodynamic Performance at 30 days
  time frame: 30 Days
  description: Acceptable Bio-prosthesis Hemodynamic Performance at 30 days, defined as:
  Mean gradient < 20mmHg
  Less than moderate aortic regurgitation (perivalvular and transvalvular)
  measure: Occurrence of the following adverse events echocardiogram during follow-up
  time frame: 5 Years
  description: Occurrence of the following adverse events echocardiogram during follow-up (The rate of follow events during the follow-up)
  All-cause mortality
  All stroke
  Life-threatening bleeding
  Acute MI
  Heart failure hospitalizations
  New permanent pacemaker implantation
  Major vascular complication
  Acute kidney injury
  Aortic valve re-intervention (surgical or transcatheter)
  Valve thrombosis
  Structural valve deterioration
  measure: Technical success is defined as the following
  time frame: During the Procedure
  description: Technical success (at exit from procedure room) (VARC-3[1]) (The rate of Technical success at the Procedure)
  Freedom from mortality
  Successful access, delivery of the device, and retrieval of the delivery system
  Correct positioning of a single prosthetic heart valve into the proper anatomical location
  Freedom from surgery or intervention related to the device or a major vascular or access-related, or cardiac structural complication
  measure: The rate of device success is defined as the following
  time frame: Up to 1 week
  description: Device success (in-hospital) (VARC-3[1]) (The rate of device success during the in-hospital)
  Freedom from mortality
  Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication
  Intended performance of the valve (mean gradient < 20 mmHg, peak velocity <3 m/s, and less than moderate aortic regurgitation)
  measure: The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:
  time frame: Up to 1 week
  description: Acceptable valve function at pre-discharge by echocardiogram (The rate of follow events during the follow-up)
  Freedom from moderate or greater patient-prosthesis mismatch (PPM)
  MPG <20mmHg
  Freedom from moderate or greater regurgitation (transvalvular and paravalvular)
  Freedom from reoperation or intervention
  measure: The rate of freedom from severe coronary overlap assessed by post-implant angiogram
  time frame: immediately after the procedure
  description: Freedom from severe coronary overlap assessed by post-implant angiogram
  measure: The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT
  time frame: 30-Days
  description: Freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT (post-implant 30-day CT scan is not mandatory for each subjects)
  measure: The rate of freedom from mild or greater PVL by echocardiogram during follow-up
  time frame: 5 Years
  description: Freedom from mild or greater PVL by echocardiogram during follow-up
  measure: New York Heart Association (NYHA) classification during follow-up
  time frame: 5 Years
  description: New York Heart Association (NYHA) classification during follow-up
  arm group label: procedure
  arm group type: Experimental
  description: implant valve by TAVR
  intervention type: Device
  intervention name: Venus-Vitae Transcatheter Heart Valve System
  description: The Venus-Vitae THV is comprised of balloon-expandable and radiopaque cobalt-chromium alloy frame, porcine pericardium tri-leaflet, porcine pericardium inner skirt, polyurethane outer skirt, PTFE assembly sutures, and three radiopaque gold markers (Figure 1). The valve utilizes Venus Endura technology and stored in a non-aqueous condition.
  arm group label: procedure
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Aortic Valve Stenosis
  mesh term: Constriction, Pathologic
  sharing ipd: No