<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/NCT02221921</url>
  </required_header>
  <id_info>
    <org_study_id>U0000SYV</org_study_id>
    <secondary_id>MicroPort Medical</secondary_id>
    <nct_id>NCT02221921</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI</brief_title>
  <official_title>Clinical Evaluation of the Safety and Performance of the MicroPort's Transcatheter Aortic Valve and Delivery System for Treatment of Severe Aortic Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai MicroPort Medical (Group) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai MicroPort Medical (Group) Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and effectiveness of the MicroPort's&#xD;
      Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic&#xD;
      stenosis who are considered unsuitable for Surgical Valve Replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Evaluate the performance, safety and clinical benefit of MicroPort's aortic valve&#xD;
           prosthesis and delivery system in intervention by peripheral artery.&#xD;
&#xD;
        2. The study Continuous observe 12 months of safety and efficacy. Approximately 89 patients&#xD;
           are recruited in the study with native aortic valve stenosis which are considered&#xD;
           unsuitable for Surgical Valve Replacement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2016</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>All cause mortality or major stroke at 12 months.</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>MACCE(major adverse cardiovascular and cerebrovascular events)</measure>
    <time_frame>30 days, 3, 6 and 12 months</time_frame>
    <description>MACCE is defined as a composite of:&#xD;
Myocardial infarction (MI)&#xD;
Hemorrhage&#xD;
renal failure&#xD;
vascular complications&#xD;
block&#xD;
ventricular arrhythmias</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>7 days post-operation</time_frame>
    <description>Device success is defined as&#xD;
The device successfully enter the vascular approach, transport and release&#xD;
The valve is placed in the correct anatomical position&#xD;
The valve achieve the expected effect (mean aortic pressure &lt; 20mmHg or peak velocity &lt; 3m/s, with no severe aortic regurgitation or paravalvular leakage)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Valve performance</measure>
    <time_frame>30 days, 3, 6 and 12 months</time_frame>
    <description>Valve performance means:&#xD;
Transvalvular mean gradient&#xD;
Effective orifice area&#xD;
Degree of aortic valve regurgitation (transvalvular and paravalvular)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The improvement of heart function</measure>
    <time_frame>30 days, 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">89</enrollment>
  <condition>Aortic Valve Disease</condition>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Aortic Valve Calcification</condition>
  <arm_group>
    <arm_group_label>MicroPort's Transcatheter Aortic Valve and Delivery System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single arm with intervention that percutaneous implantation of the MicroPort's Transcatheter Aortic Valve and Delivery System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MicroPort's Transcatheter Aortic Valve and Delivery System</intervention_name>
    <arm_group_label>MicroPort's Transcatheter Aortic Valve and Delivery System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older, male or non pregnant women;&#xD;
&#xD;
          -  Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean&#xD;
             gradient ≥ 40 mmHg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of &lt; 1.0&#xD;
             cm2 (or AVA index &lt; 0.6 cm2/m2)&#xD;
&#xD;
          -  Symptomatic due to aortic valve stenosis as demonstrated by NYHA (New York Heart&#xD;
             Association) Functional Class ≥ II&#xD;
&#xD;
          -  Expectation of life&gt;12 months&#xD;
&#xD;
          -  Calcific aortic stenosis, which is suitable for transcatheter aortic valve&#xD;
             implantation anatomically&#xD;
&#xD;
          -  is evaluated by at least two cardiovascular physicians, and they agreed that medical&#xD;
             factors precluding operation suitable for surgery (the probability of death or&#xD;
             serious, irreversible morbidity exceeded 50%)&#xD;
&#xD;
          -  The subject agreed to comply follow-up evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment&#xD;
&#xD;
          -  aortic valve is a congenital unicuspid valve, or is non-calcified.&#xD;
&#xD;
          -  Any therapeutic invasive cardiac procedure resulting in a permanent implant that is&#xD;
             performed within 30 days&#xD;
&#xD;
          -  Implanted any heart valve prosthesis, prosthetic valve ring, severe（&gt;3＋）mitral valve&#xD;
             insufficiency&#xD;
&#xD;
          -  Blood dyscrasia such as leukopenia (WBC &lt; 3×109/L), acute anemia (Hgb &lt; 90 g/L),&#xD;
             thrombocytopenia (PLT &lt; 50×109/L), bleeding diathesis, or history of coagulopathy.&#xD;
&#xD;
          -  Untreated clinically significant coronary artery disease requiring revascularization&#xD;
&#xD;
          -  Hemodynamic instability requiring mechanical cardiac assist or mechanical hemodynamic&#xD;
             support devices&#xD;
&#xD;
          -  Need for emergency surgery for any reason&#xD;
&#xD;
          -  Hypertrophic cardiomyopathy with or without obstruction&#xD;
&#xD;
          -  Severe ventricular dysfunction with LVEF (Left ventricular ejection fraction) &lt; 20%&#xD;
&#xD;
          -  Echocardiographic evidence of intracardiac mass, thrombus or vegetation&#xD;
&#xD;
          -  Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months&#xD;
&#xD;
          -  A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine,&#xD;
             clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately&#xD;
             pre-medicated.&#xD;
&#xD;
          -  Native aortic annulus size &lt; 17 mm or&gt; 29 mm.&#xD;
&#xD;
          -  Patient refuses aortic valve replacement surgery.&#xD;
&#xD;
          -  Cerebrovascular Accident (CVA) within 6 months, including TIA (transient ischemic&#xD;
             attack).&#xD;
&#xD;
          -  Renal insufficiency (creatinine &gt; 3.0 mg/dL) and/or end stage renal disease requiring&#xD;
             chronic dialysis.&#xD;
&#xD;
          -  Life expectancy &lt; 12 months&#xD;
&#xD;
          -  Significant abdominal or thoracic aorta disease, including aneurysm, marked tortuosity&#xD;
             (hyperacute bend), aortic arch atheroma, narrowing of the abdominal aorta (especially&#xD;
             with calcification and surface irregularities), or severe &quot;unfolding&quot; and tortuosity&#xD;
             of the thoracic aorta&#xD;
&#xD;
          -  Iliofemoral vessel characteristics that would preclude safe placement of 16F to 19F&#xD;
             introducer sheath such as severe obstructive calcification, severe tortuosity&#xD;
&#xD;
          -  Active bacterial endocarditis or other active infections.&#xD;
&#xD;
          -  Bulky calcified aortic valve leaflets in close proximity to coronary ostia&#xD;
&#xD;
          -  severe incapacitating dementia.&#xD;
&#xD;
          -  Currently participating in an investigational drug or another device study that has&#xD;
             not reached its primary endpoint.&#xD;
&#xD;
          -  Researchers identify that the patients with poor compliance who cannot be completed in&#xD;
             accordance.&#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_official>
    <last_name>JunBo Ge, Medical Doctor, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Zhongshan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Liu, Medical Doctor</last_name>
    <phone>+86 13911002920</phone>
    <email>davidliu@coremed.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</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>Aortic Valve Disease</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/NCT02221921
org study id: U0000SYV
secondary id: MicroPort Medical
nct id: NCT02221921
lead sponsor: 
has dmc: Yes
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's
      Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic
      stenosis who are considered unsuitable for Surgical Valve Replacement.
1. Evaluate the performance, safety and clinical benefit of MicroPort's aortic valve
           prosthesis and delivery system in intervention by peripheral artery.

        2. The study Continuous observe 12 months of safety and efficacy. Approximately 89 patients
           are recruited in the study with native aortic valve stenosis which are considered
           unsuitable for Surgical Valve Replacement.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All cause mortality or major stroke at 12 months.
time frame: 12 months
measure: MACCE(major adverse cardiovascular and cerebrovascular events)
time frame: 30 days, 3, 6 and 12 months
description: MACCE is defined as a composite of:
Myocardial infarction (MI)
Hemorrhage
renal failure
vascular complications
block
ventricular arrhythmias
measure: Device success
time frame: 7 days post-operation
description: Device success is defined as
The device successfully enter the vascular approach, transport and release
The valve is placed in the correct anatomical position
The valve achieve the expected effect (mean aortic pressure < 20mmHg or peak velocity < 3m/s, with no severe aortic regurgitation or paravalvular leakage)
measure: Valve performance
time frame: 30 days, 3, 6 and 12 months
description: Valve performance means:
Transvalvular mean gradient
Effective orifice area
Degree of aortic valve regurgitation (transvalvular and paravalvular)
measure: The improvement of heart function
time frame: 30 days, 3, 6 and 12 months
arm group label: MicroPort's Transcatheter Aortic Valve and Delivery System
arm group type: Experimental
description: single arm with intervention that percutaneous implantation of the MicroPort's Transcatheter Aortic Valve and Delivery System
intervention type: Device
intervention name: MicroPort's Transcatheter Aortic Valve and Delivery System
arm group label: MicroPort's Transcatheter Aortic Valve and Delivery System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: JunBo Ge, Medical Doctor, Professor
role: Principal Investigator
affiliation: Shanghai Zhongshan Hospital
last name: David Liu, Medical Doctor
phone: +86 13911002920
email: davidliu@coremed.com.cn
facility: 
country: China
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Aortic Valve Disease
mesh term: Constriction, Pathologic