<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/NCT04414878</url>
  </required_header>
  <id_info>
    <org_study_id>SUPERIOR-2017</org_study_id>
    <nct_id>NCT04414878</nct_id>
  </id_info>
  <brief_title>VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial</brief_title>
  <official_title>A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai MicroPort CardioFlow Medtech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai MicroPort CardioFlow Medtech Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness&#xD;
      of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of&#xD;
      severe aortic stenosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This a prospective, multi-center, single-arm, objective performance clinical investigation,&#xD;
      aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II&#xD;
      Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 145&#xD;
      subjects will be enrolled in 18 clinical centers within China. Clinical or telephone&#xD;
      follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve&#xD;
      implantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 31, 2018</start_date>
  <completion_date type="Anticipated">January 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2022</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 all-cause mortality at 12 months post implantation</measure>
    <time_frame>12 months post implantation</time_frame>
    <description>Rate of all-cause mortality including cardiovascular and non-cardiovascular death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Valve function-mean prosthetic valve gradient</measure>
    <time_frame>at 30 days, 6 months, and 1 year post implantation</time_frame>
    <description>Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Valve function- effective orifice area</measure>
    <time_frame>at 30 days, 6 months, and 1 year post implantation</time_frame>
    <description>Effective orifice area measured by transthoracic echocardiography (TTE)(in cm^2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Valve function- degree of prosthetic valve regurgitation</measure>
    <time_frame>at 30 days, 6 months, and 1 year post implantation</time_frame>
    <description>Degree of prosthetic valve regurgitation including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of safety events according to VARC2</measure>
    <time_frame>at 30 days, 6 months, 1 year and annually up to 5 years post implantation</time_frame>
    <description>Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, conduction disturbance and arrhythmias, and new permanent pacemaker implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of other TAVI-related complications</measure>
    <time_frame>at 30 days, 6 months, 1 year and annually up to 5 years post implantation</time_frame>
    <description>Rate of other TAVI-related complications including conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, and TAV-in-TAV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of major adverse cardiac and cerebrovascular events(MACCE)</measure>
    <time_frame>at 30 days, 6 months, 1 year and annually up to 5 years post implantation</time_frame>
    <description>Rate of MACCE including all-cause mortality, stroke, myocardial infarction, re-intervention, arrhythmias, and conduction disturbances</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of device success</measure>
    <time_frame>at immediate post implantation</time_frame>
    <description>Rate of device success, assessed by death, the access, delivery, deployment and implantation of the device, prosthetic valve position and valve function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of balloon pre-dilation success</measure>
    <time_frame>at immediate post implantation</time_frame>
    <description>Rate of balloon pre-dilation success, assessed by the access, delivery, pre-dilation and retrieval of the balloon catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of balloon post-dilation success</measure>
    <time_frame>at immediate post implantation</time_frame>
    <description>Rate of balloon post-dilation success, assessed by the access, delivery, post-dilation and retrieval of the balloon catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of procedure success</measure>
    <time_frame>at immediate post implantation</time_frame>
    <description>Rate of procedure success, assessed by the device success and the peri-procedural complications</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">145</enrollment>
  <condition>Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>Single arm clinical investigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in experimental group will be implanted with the VitaFlow™ II Transcatheter Aortic Valve System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VitaFlow™ II Transcatheter Aortic Valve System</intervention_name>
    <description>VitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire</description>
    <arm_group_label>Single arm clinical investigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age≥70 years;&#xD;
&#xD;
          2. Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean&#xD;
             transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area&lt;0.8cm² (or&#xD;
             EOA index&lt;0.5cm²/m²);&#xD;
&#xD;
          3. NYHA≥II class;&#xD;
&#xD;
          4. Estimated life-expectancy&gt;12 months after implantation of the prosthetic valve;&#xD;
&#xD;
          5. Anatomically suitable for the transcatheter aortic valve implantation procedure;&#xD;
&#xD;
          6. The patients considered to high-risk or not suitable for surgical aortic valve&#xD;
             replacement (SAVR), as assessed by two or above heart surgeons; The patient has been&#xD;
             informed of the nature of the study, is willing to enroll in the study by signing a&#xD;
             patient informed consent and agreeing to the scheduled follow up requirement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute myocardial infarction (MI) in last 30 days before the treatment;&#xD;
&#xD;
          2. Aortic root anatomy not suitable for the implantation of the transcatheter aortic&#xD;
             valve；&#xD;
&#xD;
          3. Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation);&#xD;
             moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe&#xD;
             tricuspid valve regurgitation;&#xD;
&#xD;
          4. Previous implantation of heart valve at any position；&#xD;
&#xD;
          5. Hemodynamic instability requiring mechanical hemodynamic support devices;&#xD;
&#xD;
          6. Need for emergency surgery for any reason;&#xD;
&#xD;
          7. Hypertrophic cardiomyopathy with obstruction;&#xD;
&#xD;
          8. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) &lt;&#xD;
             20%;Severe right ventricular dysfunction;&#xD;
&#xD;
          9. Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;&#xD;
&#xD;
         10. Known hypersensitivity or contraindication to all anticoagulation/antiplatelet&#xD;
             regimens, to nitinol, contrast media or other relevant elements.&#xD;
&#xD;
         11. Congenital aortic valve stenosis or unicuspid aortic valve;&#xD;
&#xD;
         12. Vascular diseases or anatomical condition preventing the device access;&#xD;
&#xD;
         13. Active endocarditis or other active infections at the time of treatment;&#xD;
&#xD;
         14. Participating in another trial and the primary endpoint is not achieved.&#xD;
&#xD;
         15. Inability to comply with the clinical investigation follow-up or other requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bi Jie</last_name>
    <phone>(86)(21)38954600</phone>
    <email>jbi@microport.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhujun Cai, PhD</last_name>
    <phone>(86)(21)38954600</phone>
    <email>zjcai@microport.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fuwai Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yongjian Wu, Prof</last_name>
      <phone>13701387189</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Junbo Ge, Prof</last_name>
      <phone>13901977506</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mao Chen, Prof</last_name>
      <phone>18980602046</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian-An Wang, Prof</last_name>
      <phone>13805786328</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 31, 2020</last_update_submitted>
  <last_update_submitted_qc>May 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</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>
  <!-- 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/NCT04414878
org study id: SUPERIOR-2017
nct id: NCT04414878
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness
      of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of
      severe aortic stenosis.
This a prospective, multi-center, single-arm, objective performance clinical investigation,
      aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II
      Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 145
      subjects will be enrolled in 18 clinical centers within China. Clinical or telephone
      follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve
      implantation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of all-cause mortality at 12 months post implantation
time frame: 12 months post implantation
description: Rate of all-cause mortality including cardiovascular and non-cardiovascular death
measure: Valve function-mean prosthetic valve gradient
time frame: at 30 days, 6 months, and 1 year post implantation
description: Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg)
measure: Valve function- effective orifice area
time frame: at 30 days, 6 months, and 1 year post implantation
description: Effective orifice area measured by transthoracic echocardiography (TTE)(in cm^2)
measure: Valve function- degree of prosthetic valve regurgitation
time frame: at 30 days, 6 months, and 1 year post implantation
description: Degree of prosthetic valve regurgitation including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)
measure: Rate of safety events according to VARC2
time frame: at 30 days, 6 months, 1 year and annually up to 5 years post implantation
description: Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, conduction disturbance and arrhythmias, and new permanent pacemaker implantation
measure: Rate of other TAVI-related complications
time frame: at 30 days, 6 months, 1 year and annually up to 5 years post implantation
description: Rate of other TAVI-related complications including conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, and TAV-in-TAV
measure: Rate of major adverse cardiac and cerebrovascular events(MACCE)
time frame: at 30 days, 6 months, 1 year and annually up to 5 years post implantation
description: Rate of MACCE including all-cause mortality, stroke, myocardial infarction, re-intervention, arrhythmias, and conduction disturbances
measure: Rate of device success
time frame: at immediate post implantation
description: Rate of device success, assessed by death, the access, delivery, deployment and implantation of the device, prosthetic valve position and valve function
measure: Rate of balloon pre-dilation success
time frame: at immediate post implantation
description: Rate of balloon pre-dilation success, assessed by the access, delivery, pre-dilation and retrieval of the balloon catheter
measure: Rate of balloon post-dilation success
time frame: at immediate post implantation
description: Rate of balloon post-dilation success, assessed by the access, delivery, post-dilation and retrieval of the balloon catheter
measure: Rate of procedure success
time frame: at immediate post implantation
description: Rate of procedure success, assessed by the device success and the peri-procedural complications
arm group label: Single arm clinical investigation
arm group type: Experimental
description: Subjects in experimental group will be implanted with the VitaFlow™ II Transcatheter Aortic Valve System
intervention type: Device
intervention name: VitaFlow™ II Transcatheter Aortic Valve System
description: VitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire
arm group label: Single arm clinical investigation
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Bi Jie
phone: (86)(21)38954600
email: jbi@microport.com
last name: Zhujun Cai, PhD
phone: (86)(21)38954600
email: zjcai@microport.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic