<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/NCT03788590</url>
  </required_header>
  <id_info>
    <org_study_id>LT-2017-01</org_study_id>
    <nct_id>NCT03788590</nct_id>
  </id_info>
  <brief_title>Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System</brief_title>
  <acronym>TAVI</acronym>
  <official_title>A Prospective, Multicenter, Single-armed Trial That Aims to Evaluate the Safety and Efficacy of Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ningbo Jenscare Biotechnology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ningbo Jenscare Biotechnology Co., Ltd.</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 of this study is to demonstrate that transcatheter artificial aortic valve and&#xD;
      transcatheter artificial heart values delivery system is associated with a reduction of&#xD;
      all-cause mortality in severe aortic stenosis or insufficiency patients who are high risk or&#xD;
      ineligible for aortic valve replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aortic valve diseases is usually caused by rheumatic fever, congenital aortic valve&#xD;
      structural abnormality or degenerative aortic valve calcification. Transcatheter aortic valve&#xD;
      implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR)&#xD;
      with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis,&#xD;
      who were considered to be at very high or prohibitive operative risk.&#xD;
&#xD;
      This project take the incidence of all-cause mortality at 12 months since TAVI as the primary&#xD;
      endpoint to evaluate the safety and efficacy, then take the procedure success rate, device&#xD;
      success rate, incidence of severe adverse events, device operative performance, prosthetic&#xD;
      valve performance and quality of life to evaluate transcatheter artificial aortic valve and&#xD;
      transcatheter artificial heart values delivery system of Ningbo Jenscare Biotechnology Co.,&#xD;
      Ltd. in clinical application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 23, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 23, 2021</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</measure>
    <time_frame>12 month</time_frame>
    <description>Cumulative incidence of a combination of all cause death at 12 month after TAVI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure success rate</measure>
    <time_frame>During the TAVI procedure</time_frame>
    <description>Documentation of no death occurred during or within 72 hours after TAVI, no conversion to conventional cardiopulmonary bypass, the value was placed in the correct anatomical position and achieve the desired effect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success rate</measure>
    <time_frame>During the TAVI procedure</time_frame>
    <description>Documentation of the device was implanted successfully, placed in the correct anatomical position and achieve the desired effect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of severe adverse events</measure>
    <time_frame>During the TAVI procedure and 3 days,7 days, 30 days, 3 months, 6 months, 12 months after TAVI</time_frame>
    <description>Documentation of the serious long-term complications, including mortality, stroke, transient ischemic stroke, myocardial infarction, dialysis and reinterventions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of device operative performance</measure>
    <time_frame>During the TAVI procedure</time_frame>
    <description>Using the following measure (loading and releasing properties of artificial aortic valve; pushing, emptying, withdrawing, developing performance, fracture of the delivery system) that can be converted to utilities using an algorithm. Utilities range from 1 to 3, with 3 representing perfect performance, and 1 corresponding to the worst performance state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic assessment of valve performance</measure>
    <time_frame>30 days, 3 months, 6 months, 12 months after TAVI</time_frame>
    <description>Using the following measures: effective orifice area (EOA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic assessment of valve performance</measure>
    <time_frame>30 days, 3 months, 6 months, 12 months after TAVI</time_frame>
    <description>Using the following measures: transvalvular mean gradient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation and improvement of quality of life</measure>
    <time_frame>Preoperative and 30 days, 3 months, 6 months, 12 months after TAVI</time_frame>
    <description>Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic assessment of valve performance</measure>
    <time_frame>30 days, 3 months, 6 months, 12 months after TAVI</time_frame>
    <description>Using the following measures: peak flow velocity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic assessment of valve performance</measure>
    <time_frame>30 days, 3 months, 6 months, 12 months after TAVI</time_frame>
    <description>Using the following measures: degree of aortic valve regurgitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic assessment of valve performance</measure>
    <time_frame>30 days, 3 months, 6 months, 12 months after TAVI</time_frame>
    <description>Using the following measures: degree of perivalvular leakage</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">133</enrollment>
  <condition>Severe Aortic Stenosis</condition>
  <condition>Aortic Regurgitation</condition>
  <arm_group>
    <arm_group_label>Jenscare TAVI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing a Jenscare TAVI and delivery system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Jenscare TAVI</intervention_name>
    <description>Jenscare TAVI and delivery system will implant a percutaneous bioprosthesis value, which is positioned in the native aortic valve, plays a role to control blood flow, and help your heart to work better. It may also shorten your recovery time to getting back to everyday activities.</description>
    <arm_group_label>Jenscare TAVI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects ≥ 65 years of age;&#xD;
&#xD;
          -  Severe aortic stenosis, as defined by ultrasonic cardiogram (peak velocity ≥4.0 m/s,&#xD;
             or mean transaortic systolic pressure gradient ≥40 mmHg, or an aortic valve area of&#xD;
             &lt;1.0 cm2) or combined merger; severe aortic insufficiency (regurgitation ≥+++ or&#xD;
             regurgitation area ≥0.3cm2) combined with left ventricular dilatation ( LVESD≥50mm or&#xD;
             LVEDD≥65mm);or severe aortic valve insufficiency combined with left ventricular&#xD;
             systolic dysfunction (LVEF&lt;50%);&#xD;
&#xD;
          -  Symptoms suggestive of aortic stenosis, NYHA class III or IV;&#xD;
&#xD;
          -  Patients who are considered unsuitable for surgery are considered by two or more than&#xD;
             two cardiovascular specialists (≥6% using Society of Thoracic Surgeons scoring system&#xD;
             estimation; or there is a severe and irreversible organ damage to the patient, such as&#xD;
             lung disease, liver disease, kidney disease and so on; or the patient's physical&#xD;
             weakness can not be tolerated by surgery; or have other factors affecting surgery,&#xD;
             such as postoperative chest radiosurgery, thoracic deformity, and diffuse severe&#xD;
             calcification of the aorta, etc);&#xD;
&#xD;
          -  A life expectancy of &gt; 1 year;&#xD;
&#xD;
          -  Voluntarily participate in and sign the informed consent form and willing to undergo&#xD;
             the related examination and clinical follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Untreated severe coronary stenosis and needs revascularization; or acute myocardial&#xD;
             infarction occurred within 1 months, or coronary stent implantation in 1 month;&#xD;
&#xD;
          -  Artificial heart valve and artificial valve ring have been implanted；&#xD;
&#xD;
          -  Severe mitral insufficiency (regurgitation ≥+++) or mitral stenosis (valvular area&lt;1.5&#xD;
             cm2)；&#xD;
&#xD;
          -  left ventricular or atrial thrombus;&#xD;
&#xD;
          -  Aortic annulus diameter &lt;17mm or &gt;27 mm;&#xD;
&#xD;
          -  Severe left ventricular dysfunction, ejection fraction &lt;20%；&#xD;
&#xD;
          -  Severe pulmonary hypertension or severe right ventricular dysfunction；&#xD;
&#xD;
          -  The ascending aortic ≥5cm or Aortic root diameter ≥4.5cm;&#xD;
&#xD;
          -  Cerebrovascular event in last 3 months；&#xD;
&#xD;
          -  Active endocarditis or other active infection;&#xD;
&#xD;
          -  Severe renal failure and requires long-term dialysis treatment；&#xD;
&#xD;
          -  Severe liver dysfunction；&#xD;
&#xD;
          -  Active peptic ulcer；&#xD;
&#xD;
          -  Severe coagulation dysfunction; it is known that all anticoagulant schemes are taboo&#xD;
             or allergic, or anticoagulants can not be used in the process of testing；&#xD;
&#xD;
          -  Severe respiratory failure；&#xD;
&#xD;
          -  Severe Alzheimer's disease；&#xD;
&#xD;
          -  Patients who were enrolled in any other study in one month;&#xD;
&#xD;
          -  Other cases which the researchers believe that it is not suitable to participate in.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peng Cao, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Ningbo Jenscare Biotechnology Co., Ltd.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaolin Wang, Master</last_name>
    <phone>8617717875521</phone>
    <phone_ext>057463935666</phone_ext>
    <email>Alice.w@linksmed.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhigang Song, Proferssor</last_name>
    <phone>8613917856919</phone>
    <phone_ext>057463935666</phone_ext>
    <email>zhgsong@smmu.edu.cn</email>
  </overall_contact_backup>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>January 5, 2019</last_update_submitted>
  <last_update_submitted_qc>January 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</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 Insufficiency</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/NCT03788590
org study id: LT-2017-01
nct id: NCT03788590
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and
      transcatheter artificial heart values delivery system is associated with a reduction of
      all-cause mortality in severe aortic stenosis or insufficiency patients who are high risk or
      ineligible for aortic valve replacement.
Aortic valve diseases is usually caused by rheumatic fever, congenital aortic valve
      structural abnormality or degenerative aortic valve calcification. Transcatheter aortic valve
      implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR)
      with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis,
      who were considered to be at very high or prohibitive operative risk.

      This project take the incidence of all-cause mortality at 12 months since TAVI as the primary
      endpoint to evaluate the safety and efficacy, then take the procedure success rate, device
      success rate, incidence of severe adverse events, device operative performance, prosthetic
      valve performance and quality of life to evaluate transcatheter artificial aortic valve and
      transcatheter artificial heart values delivery system of Ningbo Jenscare Biotechnology Co.,
      Ltd. in clinical application.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause mortality
time frame: 12 month
description: Cumulative incidence of a combination of all cause death at 12 month after TAVI
measure: Procedure success rate
time frame: During the TAVI procedure
description: Documentation of no death occurred during or within 72 hours after TAVI, no conversion to conventional cardiopulmonary bypass, the value was placed in the correct anatomical position and achieve the desired effect
measure: Device success rate
time frame: During the TAVI procedure
description: Documentation of the device was implanted successfully, placed in the correct anatomical position and achieve the desired effect
measure: Incidence of severe adverse events
time frame: During the TAVI procedure and 3 days,7 days, 30 days, 3 months, 6 months, 12 months after TAVI
description: Documentation of the serious long-term complications, including mortality, stroke, transient ischemic stroke, myocardial infarction, dialysis and reinterventions
measure: Assessment of device operative performance
time frame: During the TAVI procedure
description: Using the following measure (loading and releasing properties of artificial aortic valve; pushing, emptying, withdrawing, developing performance, fracture of the delivery system) that can be converted to utilities using an algorithm. Utilities range from 1 to 3, with 3 representing perfect performance, and 1 corresponding to the worst performance state.
measure: Echocardiographic assessment of valve performance
time frame: 30 days, 3 months, 6 months, 12 months after TAVI
description: Using the following measures: effective orifice area (EOA)
measure: Echocardiographic assessment of valve performance
time frame: 30 days, 3 months, 6 months, 12 months after TAVI
description: Using the following measures: transvalvular mean gradient
measure: Evaluation and improvement of quality of life
time frame: Preoperative and 30 days, 3 months, 6 months, 12 months after TAVI
description: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.
measure: Echocardiographic assessment of valve performance
time frame: 30 days, 3 months, 6 months, 12 months after TAVI
description: Using the following measures: peak flow velocity
measure: Echocardiographic assessment of valve performance
time frame: 30 days, 3 months, 6 months, 12 months after TAVI
description: Using the following measures: degree of aortic valve regurgitation
measure: Echocardiographic assessment of valve performance
time frame: 30 days, 3 months, 6 months, 12 months after TAVI
description: Using the following measures: degree of perivalvular leakage
arm group label: Jenscare TAVI
arm group type: Experimental
description: Patients undergoing a Jenscare TAVI and delivery system
intervention type: Device
intervention name: Jenscare TAVI
description: Jenscare TAVI and delivery system will implant a percutaneous bioprosthesis value, which is positioned in the native aortic valve, plays a role to control blood flow, and help your heart to work better. It may also shorten your recovery time to getting back to everyday activities.
arm group label: Jenscare TAVI
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Peng Cao, Doctor
role: Study Director
affiliation: Ningbo Jenscare Biotechnology Co., Ltd.
last name: Xiaolin Wang, Master
phone: 8617717875521
phone ext: 057463935666
email: Alice.w@linksmed.cn
last name: Zhigang Song, Proferssor
phone: 8613917856919
phone ext: 057463935666
email: zhgsong@smmu.edu.cn
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Aortic Valve Insufficiency