xml: <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/NCT05988450</url>
    </required_header>
    <id_info>
      <org_study_id>MVRP01-001A</org_study_id>
      <nct_id>NCT05988450</nct_id>
    </id_info>
    <brief_title>Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation</brief_title>
    <official_title>A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in Patients With Moderate-severe or Severe Functional MR (FMR)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Shenqi Medical Technology Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Shenqi Medical Technology 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>
        To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and&#xD;
        steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. in patients&#xD;
        with moderate-severe (3 +) or severe (4 +) functional MR (functional MR) who still have&#xD;
        symptoms after full treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, multi-center, single arm clinical study designed to evaluate the&#xD;
        safety and effectiveness of transcatheter mitral valve clip delivery system and steerable&#xD;
        guide catheter in patients with moderate-severe (3 +) or severe (4 +) functional MR&#xD;
        (Functional MR) who still have symptoms after adequate treatment. This trial will be&#xD;
        conducted at 41 sites in China and is planned to include a total of 118 subjects. All&#xD;
        subjects received the trial device for transcatheter mitral valve clip delivery system and&#xD;
        steerable guide catheter, and were followed up at 30 days, 6 months, and 12 months after&#xD;
        surgery. The composite endpoint of all-cause death and hospitalization for heart failure was&#xD;
        assessed at 12 months after surgery. After the 12th month follow-up, the statistical&#xD;
        analysis, clinical summary and application for product registration were carried out.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 7, 2022</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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 death and hospitalization for heart failure</measure>
      <time_frame>12 months</time_frame>
      <description>Freefrom of all-cause death and hospitalization for heart failure</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Technical success rate</measure>
      <time_frame>Immediate postoperative</time_frame>
      <description>No surgical death&#xD;
  Delivery system for successful delivery and retrieval of devices&#xD;
  Successful devices release and accurate positioning&#xD;
  No need for any emergency surgery related to the device or surgical approach</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Device success rate</measure>
      <time_frame>30 days after surgery</time_frame>
      <description>Successfully implanted valve clip&#xD;
  Transthoracic echocardiographic assessment showing MR ≤2+</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgical success rate</measure>
      <time_frame>30 days after surgery</time_frame>
      <description>Device success&#xD;
  No major adverse events occurred The major adverse event refers to the composite endpoint of death, stroke, myocardial infarction, and cardiovascular surgery due to device- or surgery-related adverse events following the atrial septum pathway via the femoral vein.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;</measure>
      <time_frame>30 days, 6 months, and 12 months after surgery</time_frame>
      <description>Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of hospitalization for heart failure at 30 days, 6 months, and 12 months after surgery;</measure>
      <time_frame>30 days, 6 months, and 12 months after surgery</time_frame>
      <description>Rate of hospitalization for heart failure at 30 days, 6 months, and 12 months after surgery;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;</measure>
      <time_frame>30 days, 6 months, and 12 months after surgery</time_frame>
      <description>The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement in 6-minute walk distance from baseline at 12 months after surgery;</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Improvement in 6-minute walk distance from baseline at 12 months after surgery;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">125</enrollment>
    <condition>Functional Mitral Regurgitation</condition>
    <arm_group>
      <arm_group_label>SQ-Kyrin TMVr System</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Transcatheter edge-to-edge mitral valve repair using SQ-Kyrin TMVr System.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SQ-Kyrin Transcatheter Mitral Valve Repair System</intervention_name>
      <description>Transcatheter mitral valve clip placement to repair the valve and correct regurgitation.</description>
      <arm_group_label>SQ-Kyrin TMVr System</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Severe functional MR (FMR) ≥3+ as determined by transthoracic echocardiography (TTE);&#xD;
  &#xD;
            2. Note: Eligible TTE must be obtained at least 30 days after the subject has been&#xD;
               stabilized on optimal therapy (including Guideline Directed Medical Therapy GDMT). In&#xD;
               the judgment of the center's cardiac team, subjects have received adequate treatment&#xD;
               according to applicable criteria, including treatment for coronary artery disease,&#xD;
               left ventricular dysfunction, MR, and heart failure (e.g., with cardiac&#xD;
               resynchronization therapy (CRT or CRT-D), implantable cardioverter-defibrillator (ICD)&#xD;
               implantation, coronary revascularization, and stable GDMT (see Appendix III for the&#xD;
               definition of GDMT).&#xD;
  &#xD;
            3. Age ≥ 18 years old, regardless of gender;&#xD;
  &#xD;
            4. Cardiac function classification NYHA class II, III or ambulatory IV a;&#xD;
  &#xD;
            5. At least one hospitalization for heart failure or subjects with high BNP &gt; 150 pg/ml&#xD;
               or high NT-proBNP &gt; 600 pg/ml in the past 12 months.&#xD;
  &#xD;
            6. Note: BNP or NT-proBNP must be obtained after the subject has stabilized on optimal&#xD;
               therapy including Guideline Directed Medical Therapy (GDMT) at least 30 days. The&#xD;
               patients can understand the purpose of the trial, voluntarily participate and sign an&#xD;
               informed consent form, and are willing to undergo relevant tests and clinical&#xD;
               follow-up.&#xD;
  &#xD;
            7. Left ventricular end-systolic diameter (LVESD)≤70mm&#xD;
  &#xD;
            8. The MR beam mainly originates from the A2/P2 area&#xD;
  &#xD;
            9. Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length of&#xD;
               anterior and posterior leaflets&gt;10mm&#xD;
  &#xD;
           10. Mitral valve effective orifice area (EOA) ≥ 4.0cm2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of mitral valve surgery;&#xD;
  &#xD;
            2. Patients with infective endocarditis or suggestive of active infection;&#xD;
  &#xD;
            3. Complicated with severe untreated coronary artery disease;&#xD;
  &#xD;
            4. Patients with pulmonary hypertension (pulmonary systolic blood pressure&gt;70mmHg);&#xD;
  &#xD;
            5. patients with transthoracic echocardiographic evidence of moderate-severe to severe&#xD;
               right ventricular dysfunction;&#xD;
  &#xD;
            6. Left heart ejection fraction &lt;20%;&#xD;
  &#xD;
            7. Patients who are extremely frail and cannot tolerate general anesthesia surgery or is&#xD;
               in the state of shock requiring circulatory support;&#xD;
  &#xD;
            8. Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy,&#xD;
               constrictive pericarditis;&#xD;
  &#xD;
            9. Severe renal insufficiency (eGFR ≤ 25 mL/min) or requiring chronic renal replacement&#xD;
               therapy;&#xD;
  &#xD;
           10. Patients with definite coagulation disorders and severe coagulation system diseases;&#xD;
  &#xD;
           11. Patients with clear contraindications to the use of anticoagulants;&#xD;
  &#xD;
           12. Patients with stroke or transient cerebral ischemic attack within 30 days;&#xD;
  &#xD;
           13. Received cardiac pacemaker therapy or cardiac resynchronization therapy (CRT, CRT-D)&#xD;
               or implanted cardioverter-defibrillator (ICD) implantation therapy within 30 days;&#xD;
  &#xD;
           14. Any intracardiac mass, left ventricular or atrial thrombus detected on transthoracic&#xD;
               echocardiography;&#xD;
  &#xD;
           15. Severe tricuspid TR;&#xD;
  &#xD;
           16. Patients with other valve disease requiring surgery or interventional therapy;&#xD;
  &#xD;
           17. Patients with severe macrovascular disease requiring surgical treatment;&#xD;
  &#xD;
           18. Severe symptomatic carotid stenosis (&gt;70% on ultrasonography) or carotid stenting&#xD;
               within 30 days;&#xD;
  &#xD;
           19. Patients with inappropriate anatomical structures of the heart and valves indicated by&#xD;
               imaging examinations;&#xD;
  &#xD;
           20. Known allergy to contrast agents and nickel-titanium memory alloy products;&#xD;
  &#xD;
           21. &lt;Resting systolic blood pressure 90 mmHg or &gt;160 mmHg;&#xD;
  &#xD;
           22. Patients with diseases that seriously affect the evaluation of treatment, such as&#xD;
               patients with severe neurological lesions affecting cognitive ability, patients with&#xD;
               malignant tumors, etc.;&#xD;
  &#xD;
           23. Patient life expectancy &lt; 12 months;&#xD;
  &#xD;
           24. Patients with severe thoracic deformity;&#xD;
  &#xD;
           25. Women who are pregnant, breastfeeding, or planning to become pregnant within the next&#xD;
               12 months.&#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>Yaling Han, MD, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>General Hospital of Northern Theater Command, PLA</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>General Hospital of Northern Theater Command, PLA</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>123005</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Functional Mitral Regurgitation</keyword>
    <keyword>Mitral Regurgitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mitral Valve Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988450
  org study id: MVRP01-001A
  nct id: NCT05988450
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and
        steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. in patients
        with moderate-severe (3 +) or severe (4 +) functional MR (functional MR) who still have
        symptoms after full treatment.
  This study is a prospective, multi-center, single arm clinical study designed to evaluate the
        safety and effectiveness of transcatheter mitral valve clip delivery system and steerable
        guide catheter in patients with moderate-severe (3 +) or severe (4 +) functional MR
        (Functional MR) who still have symptoms after adequate treatment. This trial will be
        conducted at 41 sites in China and is planned to include a total of 118 subjects. All
        subjects received the trial device for transcatheter mitral valve clip delivery system and
        steerable guide catheter, and were followed up at 30 days, 6 months, and 12 months after
        surgery. The composite endpoint of all-cause death and hospitalization for heart failure was
        assessed at 12 months after surgery. After the 12th month follow-up, the statistical
        analysis, clinical summary and application for product registration were carried out.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Rate of all-cause death and hospitalization for heart failure
  time frame: 12 months
  description: Freefrom of all-cause death and hospitalization for heart failure
  measure: Technical success rate
  time frame: Immediate postoperative
  description: No surgical death
  Delivery system for successful delivery and retrieval of devices
  Successful devices release and accurate positioning
  No need for any emergency surgery related to the device or surgical approach
  measure: Device success rate
  time frame: 30 days after surgery
  description: Successfully implanted valve clip
  Transthoracic echocardiographic assessment showing MR ≤2+
  measure: Surgical success rate
  time frame: 30 days after surgery
  description: Device success
  No major adverse events occurred The major adverse event refers to the composite endpoint of death, stroke, myocardial infarction, and cardiovascular surgery due to device- or surgery-related adverse events following the atrial septum pathway via the femoral vein.
  measure: Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;
  time frame: 30 days, 6 months, and 12 months after surgery
  description: Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;
  measure: Rate of hospitalization for heart failure at 30 days, 6 months, and 12 months after surgery;
  time frame: 30 days, 6 months, and 12 months after surgery
  description: Rate of hospitalization for heart failure at 30 days, 6 months, and 12 months after surgery;
  measure: The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;
  time frame: 30 days, 6 months, and 12 months after surgery
  description: The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;
  measure: Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);
  time frame: 12 months after surgery
  description: Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);
  measure: Improvement in 6-minute walk distance from baseline at 12 months after surgery;
  time frame: 12 months after surgery
  description: Improvement in 6-minute walk distance from baseline at 12 months after surgery;
  measure: Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;
  time frame: 12 months after surgery
  description: Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;
  arm group label: SQ-Kyrin TMVr System
  arm group type: Experimental
  description: Transcatheter edge-to-edge mitral valve repair using SQ-Kyrin TMVr System.
  intervention type: Device
  intervention name: SQ-Kyrin Transcatheter Mitral Valve Repair System
  description: Transcatheter mitral valve clip placement to repair the valve and correct regurgitation.
  arm group label: SQ-Kyrin TMVr System
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yaling Han, MD, Ph.D
  role: Principal Investigator
  affiliation: General Hospital of Northern Theater Command, PLA
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Mitral Valve Insufficiency
  sharing ipd: No