<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/NCT03025971</url>
  </required_header>
  <id_info>
    <org_study_id>S20131216</org_study_id>
    <nct_id>NCT03025971</nct_id>
  </id_info>
  <brief_title>Safety &amp; Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation</brief_title>
  <official_title>Efficacy and Safety Evaluation for The Interventional Aortic Valve Bioprosthesis and Delivery System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation With Elevated Surgical Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JC Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>JC Medical, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, multicenter, nonrandomized, single-arm, clinical study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the safety and efficacy of the J-Valve Ausper system for the treatment of&#xD;
      patients with severe aortic stenosis and/or aortic regurgitation with elevated risk for&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">April 2020</completion_date>
  <primary_completion_date type="Actual">April 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</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac function improvement</measure>
    <time_frame>30 days, 6 months, 12 months and annually up to 5 years</time_frame>
    <description>New York Heart Association (NYHA) Functional class</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Major Adverse Cardiovascular Cerebrovascular Events (MACCE)</measure>
    <time_frame>30 days, 6 months, 12 months and annually up to 5 years</time_frame>
    <description>All-cause mortality, myocardial infarction (Q-wave and non Q-wave), stroke, acute renal damage, major vascular complications, life-threatening bleeding events, or re-operation due to valvular dysfunction (surgical or interventional treatment).</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of Major Adverse Valve Related Events (MAVRE)</measure>
    <time_frame>30 days, 6 months, 12 months and annually up to 5 years</time_frame>
    <description>Valve related deaths, valve related complications, or implantation of a permanent pacemaker or defibrillator within 14 days of operation. Valve related complications include any structural degradation or non-structural dysfunction of the valve prosthesis, thrombosis, embolism, bleeding events, or valve prosthesis endocarditis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Technical Success</measure>
    <time_frame>Within 30 days post procedure</time_frame>
    <description>Implantation of the valve into the precise anatomical position of the native aortic valve.&#xD;
No valve migration&#xD;
No positioning errors.&#xD;
Paravalvular leak is less than moderate (ratio of regurgitation surface area/left ventricular surface area 25-50%).&#xD;
Successful removal of the entire delivery device.&#xD;
Implantation of the valve into the precise anatomical position of the native aortic valve.&#xD;
No valve migration&#xD;
No positioning errors.&#xD;
Paravalvular leak is less than moderate (ratio of regurgitation surface area/left ventricular surface area 25-50%).&#xD;
Successful removal of the entire delivery device.</description>
  </other_outcome>
  <other_outcome>
    <measure>Device Success</measure>
    <time_frame>Within 30 days post procedure</time_frame>
    <description>no intraoperative death,&#xD;
valve prosthesis has been accurately implanted into the anatomic position of the native aortic valve is performing its anticipated function.&#xD;
The intended performance of the bioprosthetic valve function:&#xD;
no mismatch between the valve prosthesis and the patient,&#xD;
mean transvalvular pressure gradient is ≤20 mmHg or&#xD;
peak forward aortic blood flow velocity of &lt;3.0 m/s, and no moderate or severe aortic regurgitation</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Aortic Valve Disease</condition>
  <arm_group>
    <arm_group_label>Single arm observational study</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intervention: J-Valve Transcatheter Aortic valve replacement. Prospective, multi-center, single arm observational study. Subjects will include patients with severe aortic valve stenosis and/or severe aortic regurgitation who require replacement of their native aortic valve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>J-Valve Transcatheter Aortic valve replacement</intervention_name>
    <description>Transapical Transcatheter Aortic Valve Replacement</description>
    <arm_group_label>Single arm observational study</arm_group_label>
    <other_name>TAVI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed Informed Consent&#xD;
&#xD;
          2. Age ≥18years of age&#xD;
&#xD;
          3. Presents with symptomatic aortic stenosis and/or aortic regurgitation, as well as NYHA&#xD;
             rating of NYHA ≥ II&#xD;
&#xD;
          4. Has undergone the diagnosis of at least one interventional cardiologist and two&#xD;
             cardiac surgeons: the patients are contraindicated for traditional open heart valve&#xD;
             replacement surgery (defined as 30 days post-op mortality risk &gt;50%, irreversible&#xD;
             complications, or other influential post-operative factors [such as severe&#xD;
             calcification in the ascending aorta and aortic valve, weak physical condition, chest&#xD;
             deformities, severe liver diseases, severe lung diseases, etc.] or high risk for&#xD;
             surgery (LogEuroSCORE≥20% and or STS≥8)&#xD;
&#xD;
          5. Has a diagnosis from at least one interventional cardiologist and two cardiac surgeons&#xD;
             that the patient may benefit from a valve implantation&#xD;
&#xD;
          6. Severe aortic stenosis with electrocardiography results as follows: mean transvalvular&#xD;
             pressure gradient ≥40 mmHg or maximal forward aortic blood flow velocity of ≥4.0 m/s,&#xD;
             aortic valve area &lt; 0.8 cm2 (or AVA index &lt; 0.5 cm2/m2); and/or severe aortic&#xD;
             regurgitation, electrocardiography results show symptomatic moderate regurgitation or&#xD;
             severe regurgitation&#xD;
&#xD;
          7. Without severe pulmonary arterial hypertension&#xD;
&#xD;
          8. The patient is willing to cooperate with all follow-up visits.&#xD;
&#xD;
             Anatomical Inclusion Criteria:&#xD;
&#xD;
          9. Aortic annulus &gt;19mm and &lt;29mm, standardized using cardiac CT measurements;&#xD;
&#xD;
         10. Ascending aortic diameter &lt;50mm at the sinotubular junction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with infection or who have any sign of infection&#xD;
&#xD;
          2. Previous history of endocarditis or patients with active endocarditis&#xD;
&#xD;
          3. Incidence of acute myocardial infarction within the past 30 days (Q-wave MI, or non&#xD;
             Q-wave MI with creatine kinase, an increase in troponin T)&#xD;
&#xD;
          4. Any cardiac mass discovered during echocardiography, left ventricular or atrial&#xD;
             thrombosis&#xD;
&#xD;
          5. Suffering from uncontrollable atrial fibrillation&#xD;
&#xD;
          6. Hereditary hypertrophic cardiomyopathy&#xD;
&#xD;
          7. Mitral or tricuspid valve insufficiency (Class Ⅱ regurgitation or greater)&#xD;
&#xD;
          8. Has previously undergone aortic valve implantation (mechanical valve or biological&#xD;
             valve frame)&#xD;
&#xD;
          9. Is known to be allergic to contrast agents, aspirin, heparin, ticlopidine medications,&#xD;
             nitinol or porcine products&#xD;
&#xD;
         10. Is known to be contraindicated for or is allergic to all anti-coagulants or is unable&#xD;
             to use anti-coagulants during the study&#xD;
&#xD;
         11. Is known to have one of the following conditions (according to evaluations beginning&#xD;
             from screening through the day of the procedure):&#xD;
&#xD;
               -  Other diseases that may reduce the life expectancy to less than 12 months (such&#xD;
                  as clinically recurrent or metastatic cancer, congestive heart failure, etc.)&#xD;
&#xD;
               -  Currently has drug abuse problems (such as alcohol, cocaine, heroin, etc.)&#xD;
&#xD;
               -  Plans to undergo surgery that may result in non-compliance with the study&#xD;
                  protocol or that may cause confusion in data interpretation.&#xD;
&#xD;
         12. Has experienced a cerebrovascular accident (CVA) within the last 6 months&#xD;
&#xD;
         13. Patients suffering from stenosis of the carotid, internal carotid, or vertebral&#xD;
             arteries (70%)&#xD;
&#xD;
         14. White cell count &lt;3×109/L, platelet count&lt;50×109/L&#xD;
&#xD;
         15. Hemoglobin &lt;90 g/L&#xD;
&#xD;
         16. Severely lowered left ventricular function, left ventricular ejection fraction &lt; 20 %&#xD;
&#xD;
         17. Aortic aneurysm in the abdomen or chest&#xD;
&#xD;
         18. Hepatic encephalopathy or acute active hepatitis&#xD;
&#xD;
         19. Currently undergoing dialysis or baseline creatine levels &gt;2.5 mg/dL (221μmoI/L)&#xD;
&#xD;
         20. Prone to bleeding, has a history of clotting disorders or refuses blood transfusions&#xD;
&#xD;
         21. Active ulcer or active gastrointestinal (GI) bleeding&#xD;
&#xD;
         22. Suffering from nervous system diseases that severely influence the patients' ability&#xD;
             to move or to perform daily activities&#xD;
&#xD;
         23. Patients with severe dementia&#xD;
&#xD;
         24. Any reason for emergent surgery&#xD;
&#xD;
         25. Taking part in other clinical trials for pharmaceuticals or medical devices&#xD;
&#xD;
         26. Those who are pregnant, plan to become pregnant, or who are taking estrogen or&#xD;
             estrogen-like drugs (women suspected of being pregnant must test negative on a urine&#xD;
             pregnancy test or for chorionic gonadotropin serum).&#xD;
&#xD;
             -&#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>Ji Zhang, MD</last_name>
    <role>Study Director</role>
    <affiliation>CEO, President</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fuwai Cardiovascular Hospital</name>
      <address>
        <city>Yunnan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Severe Aortic Stenosis and/or severe aortic regurgitation</keyword>
  <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>Aortic Valve Insufficiency</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03025971
org study id: S20131216
nct id: NCT03025971
lead sponsor: 
has dmc: No
A prospective, multicenter, nonrandomized, single-arm, clinical study.
To evaluate the safety and efficacy of the J-Valve Ausper system for the treatment of
      patients with severe aortic stenosis and/or aortic regurgitation with elevated risk for
      surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause Mortality
time frame: 12 months
measure: Cardiac function improvement
time frame: 30 days, 6 months, 12 months and annually up to 5 years
description: New York Heart Association (NYHA) Functional class
measure: Incidence of Major Adverse Cardiovascular Cerebrovascular Events (MACCE)
time frame: 30 days, 6 months, 12 months and annually up to 5 years
description: All-cause mortality, myocardial infarction (Q-wave and non Q-wave), stroke, acute renal damage, major vascular complications, life-threatening bleeding events, or re-operation due to valvular dysfunction (surgical or interventional treatment).
measure: Incidence of Major Adverse Valve Related Events (MAVRE)
time frame: 30 days, 6 months, 12 months and annually up to 5 years
description: Valve related deaths, valve related complications, or implantation of a permanent pacemaker or defibrillator within 14 days of operation. Valve related complications include any structural degradation or non-structural dysfunction of the valve prosthesis, thrombosis, embolism, bleeding events, or valve prosthesis endocarditis.
measure: Technical Success
time frame: Within 30 days post procedure
description: Implantation of the valve into the precise anatomical position of the native aortic valve.
No valve migration
No positioning errors.
Paravalvular leak is less than moderate (ratio of regurgitation surface area/left ventricular surface area 25-50%).
Successful removal of the entire delivery device.
Implantation of the valve into the precise anatomical position of the native aortic valve.
No valve migration
No positioning errors.
Paravalvular leak is less than moderate (ratio of regurgitation surface area/left ventricular surface area 25-50%).
Successful removal of the entire delivery device.
measure: Device Success
time frame: Within 30 days post procedure
description: no intraoperative death,
valve prosthesis has been accurately implanted into the anatomic position of the native aortic valve is performing its anticipated function.
The intended performance of the bioprosthetic valve function:
no mismatch between the valve prosthesis and the patient,
mean transvalvular pressure gradient is ≤20 mmHg or
peak forward aortic blood flow velocity of <3.0 m/s, and no moderate or severe aortic regurgitation
arm group label: Single arm observational study
arm group type: Other
description: Intervention: J-Valve Transcatheter Aortic valve replacement. Prospective, multi-center, single arm observational study. Subjects will include patients with severe aortic valve stenosis and/or severe aortic regurgitation who require replacement of their native aortic valve.
intervention type: Device
intervention name: J-Valve Transcatheter Aortic valve replacement
description: Transapical Transcatheter Aortic Valve Replacement
arm group label: Single arm observational study
other name: TAVI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ji Zhang, MD
role: Study Director
affiliation: CEO, President
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Aortic Valve Disease
mesh term: Aortic Valve Insufficiency
mesh term: Constriction, Pathologic
sharing ipd: Undecided