<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/NCT04414865</url>
  </required_header>
  <id_info>
    <org_study_id>LAUNCH-2020</org_study_id>
    <nct_id>NCT04414865</nct_id>
  </id_info>
  <brief_title>VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study</brief_title>
  <official_title>A Prospective, Multi-center, Post-market Registry Study Evaluating Safety and Effectiveness of the Microport™CardioFlow VitaFlow™Transcatheter Aortic Valve System for the Treatment of Severe Aortic 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>
      The study objective is to evaluate safety and effectiveness/performance of the Microport™&#xD;
      CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic&#xD;
      stenosis in the real world settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-arm, multi-center, observational, post-market registry study.&#xD;
      The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow™&#xD;
      Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and&#xD;
      post procedure, discharge, 30 days, 1 year and annually up to 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 26, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </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 transvalvular gradient</measure>
    <time_frame>at discharge, 30 days, 1 year and annually up to 5 years post implantation</time_frame>
    <description>Mean transvalvular gradient measured by transthoracic echocardiography (TTE)(in mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Valve function-effective orifice area</measure>
    <time_frame>at discharge, 30 days, 1 year and annually up to 5 years 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 discharge, 30 days, 1 year and annually up to 5 years 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 immediate, 30 days, 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, new permanent pacemaker implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of other TAVI-related complications</measure>
    <time_frame>at immediate, 30 days, 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, TAV-in-TAV, valve related dysfunction requiring repeat procedure (TAVI,SAVR,BAV)</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 the access, delivery, deployment and implantation of the device and the prosthetic valve function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of balloon pre-dilatation success</measure>
    <time_frame>at immediate post implantation</time_frame>
    <description>Rate of balloon pre-dilatation success, assessed by the access, delivery, pre-dilatation and retrieval of the balloon catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of balloon post-dilatation success</measure>
    <time_frame>at immediate post implantation</time_frame>
    <description>Rate of balloon pre-dilatation success, assessed by the access, delivery, post-dilatation 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 peri-procedural complications</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>single arm, treatment group</arm_group_label>
    <description>Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VitaFlow™ Transcatheter Aortic Valve System</intervention_name>
    <description>VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set</description>
    <arm_group_label>single arm, treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population includes symptomatic patients (≥70 years old ) with calcified, severe,&#xD;
        degenerative, native aortic valve stenosis who are not suitable for the surgical aortic&#xD;
        valve replacement as assessed by the heart team&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age≥70 years;&#xD;
&#xD;
          -  Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak&#xD;
             velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic&#xD;
             valve area&lt;0.8cm² (or EOA index&lt;0.5cm²/m²);&#xD;
&#xD;
          -  The patients considered to be not suitable for surgical aortic valve replacement&#xD;
             (SAVR);&#xD;
&#xD;
          -  The patient has been informed of the nature of the study, is willing to enroll in the&#xD;
             study by signing a patient informed consent and agreeing to the scheduled follow up&#xD;
             requirement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aortic root anatomy not suitable for the implantation of the transcatheter aortic&#xD;
             valve；&#xD;
&#xD;
          -  Vascular diseases or anatomical condition preventing the device access；&#xD;
&#xD;
          -  Previous implantation of mechanical or bioprosthesis valve in the aortic position；&#xD;
&#xD;
          -  Known hypersensitivity or contraindication to all anticoagulation/antiplatelet&#xD;
             regimens, to nitinol, contrast media or other relevant elements；&#xD;
&#xD;
          -  Ongoing sepsis, including active endocarditis；&#xD;
&#xD;
          -  Estimated Life expectancy&lt; 12 months；&#xD;
&#xD;
          -  Participating in another trial and the primary endpoint is not achieved.&#xD;
&#xD;
          -  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>Zhujun Cai, PhD</last_name>
    <phone>(86)(21)38954600</phone>
    <email>zjcai@micoport.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jie Bi</last_name>
    <phone>(86)(21)38954600</phone>
    <email>jbi@micoport.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ruijing Hospital，Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ruiyan Zhang, Prof</last_name>
      <phone>13601911729</phone>
      <email>zhangruiyan@263.net</email>
    </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>Daxin Zhou, Prof</last_name>
      <phone>13801641512</phone>
      <email>zhou.daxin@zs-hospital.sh.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 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/NCT04414865
org study id: LAUNCH-2020
nct id: NCT04414865
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study objective is to evaluate safety and effectiveness/performance of the Microport™
      CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic
      stenosis in the real world settings.
This is a prospective, single-arm, multi-center, observational, post-market registry study.
      The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow™
      Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and
      post procedure, discharge, 30 days, 1 year and annually up to 5 years.
observational model: Cohort
time perspective: Prospective
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 transvalvular gradient
time frame: at discharge, 30 days, 1 year and annually up to 5 years post implantation
description: Mean transvalvular gradient measured by transthoracic echocardiography (TTE)(in mmHg)
measure: Valve function-effective orifice area
time frame: at discharge, 30 days, 1 year and annually up to 5 years 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 discharge, 30 days, 1 year and annually up to 5 years 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 immediate, 30 days, 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, new permanent pacemaker implantation
measure: Rate of other TAVI-related complications
time frame: at immediate, 30 days, 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, TAV-in-TAV, valve related dysfunction requiring repeat procedure (TAVI,SAVR,BAV)
measure: Rate of device success
time frame: at immediate post implantation
description: Rate of device success, assessed by the access, delivery, deployment and implantation of the device and the prosthetic valve function
measure: Rate of balloon pre-dilatation success
time frame: at immediate post implantation
description: Rate of balloon pre-dilatation success, assessed by the access, delivery, pre-dilatation and retrieval of the balloon catheter
measure: Rate of balloon post-dilatation success
time frame: at immediate post implantation
description: Rate of balloon pre-dilatation success, assessed by the access, delivery, post-dilatation 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 peri-procedural complications
arm group label: single arm, treatment group
description: Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System
intervention type: Device
intervention name: VitaFlow™ Transcatheter Aortic Valve System
description: VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set
arm group label: single arm, treatment group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Zhujun Cai, PhD
phone: (86)(21)38954600
email: zjcai@micoport.com
last name: Jie Bi
phone: (86)(21)38954600
email: jbi@micoport.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic