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/NCT06021509</url>
    </required_header>
    <id_info>
      <org_study_id>YM-2022-001</org_study_id>
      <nct_id>NCT06021509</nct_id>
    </id_info>
    <brief_title>Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation</brief_title>
    <official_title>A Prospective, Multicenter, Single-arm Clinical Study of NovoClasp Transcatheter Mitral Valve Clip and Steerable Guide Catheter for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation (DMR)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Enlight Medical Technologies (Shanghai) Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Enlight Medical Technologies (Shanghai) 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 validate the safety and efficacy of transcatheter edge-to-edge repair (TEER) using the&#xD;
        NovoClasp® transcatheter mitral valve clip and steerable guide catheter in the treatment of&#xD;
        moderate to severe and severe degenerative mitral regurgitation (DMR).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This trial is a prospective multi-center single-arm confirmatory study. A total of 102&#xD;
        subjects will be enrolled in multiple centers nationwide. Subjects who meet the trial&#xD;
        requirements, fulfill the inclusion criteria, voluntarily participate in the study, and&#xD;
        provide informed consent will undergo mitral edge-to-edge repair using the NovoClasp®&#xD;
        transcatheter mitral valve clip system and steerable guide catheter for the treatment of&#xD;
        moderate to severe or severe degenerative mitral regurgitation (DMR). Follow-up assessments&#xD;
        will be conducted at discharge, as well as at 30 days, 90 days, 180 days, and 360 days&#xD;
        postoperatively. The primary endpoint will be the treatment effectiveness rate at 360 days&#xD;
        post-surgery. Secondary endpoint measures include treatment effectiveness at other time&#xD;
        points, surgical success rate, all-cause mortality, device/procedure-related mortality,&#xD;
        incidence of adverse events, and serious adverse event rates. The trial aims to&#xD;
        comprehensively assess the safety and efficacy of the NovoClasp® transcatheter mitral valve&#xD;
        clip and steerable guide catheter produced by Enlight Medical Technologies (Shanghai) Co.,&#xD;
        Ltd..&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 15, 2022</start_date>
    <completion_date type="Anticipated">June 25, 2028</completion_date>
    <primary_completion_date type="Anticipated">June 25, 2024</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>Treatment effectiveness rate</measure>
      <time_frame>1 year</time_frame>
      <description>Treatment effectiveness is defined as the success of the procedure with the mitral valve regurgitation sustained at moderate or lower (&lt;=2+) after the surgery, without major adverse events or secondary interventions (interventional or surgical).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Procedural success rate</measure>
      <time_frame>immediately after procedure</time_frame>
      <description>Successful implantation of a single device as intended by the operator, successful retrieval of the delivery system, absence of device migration, dislodgment, embolization, related complications, or other unforeseen incidents.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Procedural success rate</measure>
      <time_frame>During the perioperative period</time_frame>
      <description>Defined as successful completion of the investigational procedure as intended by the operator (implantation of at least 1 study device) and reduction of mitral valve regurgitation to moderate or below (&lt;=2+), without open surgery, major adverse events during the perioperative period, or secondary interventions (interventional or surgical).&#xD;
  Note: Major adverse events include cardiovascular-related deaths, stroke, myocardial infarction, need for renal replacement therapy, severe bleeding (hemoglobin decrease &gt;=3g/dL compared to baseline, or requiring &gt;=3 units of blood transfusion), or organ damage, failure, or death dur to blood loss.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Treatment success</measure>
      <time_frame>30 days, 180 days</time_frame>
      <description>Treatment effectiveness is defined as the success of the procedure with the mitral valve regurgitation sustained at moderate or lower (&lt;=2+) after the surgery, without major adverse events or secondary interventions (interventional or surgical).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in New York Heart Association (NYHA) Functional Classification</measure>
      <time_frame>through study completiong, an average of 1 year.</time_frame>
      <description>The NYHA Classification provides nomenclature to describe an overall cardiac appraisal of the status of a patient with heart disease.&#xD;
  Class I: Patients with cardiac disease but without resulting limitation of physical activity.&#xD;
  Class II: patients with cardiac disease resulting in slight limitation of physical activity.&#xD;
  Class III: Patients with cardiac disease resulting in marked limitation of physical activity.&#xD;
  Class IV: Patient with cardiac disease resulting in inability to carry on any physical activity without discomfor.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>All cause mortality</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Device/Procedure-related mortality</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Major adverse events</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Serious adverse events</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with device-related adverse events</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">102</enrollment>
    <condition>Degenerative Mitral Valve Disease</condition>
    <arm_group>
      <arm_group_label>NovoClasp system</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NovoClasp® transcatheter mitral valve clip and steerable guide catheter</intervention_name>
      <description>The experimental device is a class III implanted valve device, which will be used to treat the mitral valve regurgitation via transcatheter edge-to-edge repair.</description>
      <arm_group_label>NovoClasp system</arm_group_label>
      <other_name>transcatheter edge-to-edge repair for mitral valve</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Subjects must meet all of the following criteria to be eligible for this study.&#xD;
  &#xD;
            1. Age 18 years.&#xD;
  &#xD;
            2. Willingness to comply with the protocol requirements and data collection procedures,&#xD;
               ability to understand the purpose of the trial, voluntary participation, and signing&#xD;
               of informed consent by the subject or legal guardian.&#xD;
  &#xD;
            3. Confirmation by echocardiography of moderate to severe (3+) or severe (4+)&#xD;
               degenerative mitral regurgitation.&#xD;
  &#xD;
            4. Echocardiography showing left ventricular ejection fraction 30%, left ventricular&#xD;
               end-systolic diameter (LVESD) 60mm, and pulmonary artery systolic pressure (PASP) 70&#xD;
               mmHg.&#xD;
  &#xD;
            5. NYHA functional classification II-IV.&#xD;
  &#xD;
            6. Presence of a primary regurgitant jet; if a secondary regurgitant jet is present, it&#xD;
               should be clinically insignificant based on investigator assessment.&#xD;
  &#xD;
            7. Evaluated by a multidisciplinary team as suitable for the investigational procedure&#xD;
               using the study device.&#xD;
  &#xD;
            8. Society of Thoracic Surgeons (STS) score 4 or evaluated as high surgical risk for&#xD;
               mitral valve repair by two cardiac surgeons.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Subjects meeting any of the following criteria are not eligible for this study.&#xD;
  &#xD;
            1. History of prior mitral valve surgery or heart transplant.&#xD;
  &#xD;
            2. Severe organ dysfunction that may affect study evaluation, including but not limited&#xD;
               to:&#xD;
  &#xD;
                 1. Right heart failure or biventricular heart failure.&#xD;
  &#xD;
                 2. Severe restrictive or obstructive lung disease (COPD) requiring continuous oxygen&#xD;
                    therapy or oral steroid treatment.&#xD;
  &#xD;
                 3. Severe renal insufficiency requiring or likely to require continuous renal&#xD;
                    replacement therapy (CRRT) or dialysis postoperatively.&#xD;
  &#xD;
                 4. Severe carotid artery stenosis confirmed by imaging to be &gt;70%.&#xD;
  &#xD;
            3. History of cerebrovascular accident within the past 1 month.&#xD;
  &#xD;
            4. Acute deep vein thrombosis or acute pulmonary embolism history.&#xD;
  &#xD;
            5. Any known active infection.&#xD;
  &#xD;
            6. Active infective endocarditis (eligible 6 weeks after standard antimicrobial&#xD;
               treatment), rheumatic heart valve disease, or radiation-induced valve disease.&#xD;
  &#xD;
            7. Cardiac or major vascular surgical or interventional procedure within 30 days&#xD;
               (coronary angiography is allowed).&#xD;
  &#xD;
            8. Coexisting moderate or greater valvular disease (aortic valve, tricuspid valve,&#xD;
               pulmonary valve stenosis or regurgitation).&#xD;
  &#xD;
            9. Known other cardiac or major vascular diseases requiring surgical or interventional&#xD;
               intervention, including but not limited to coronary artery disease, myocardial&#xD;
               disease, aortic disease (except for coronary angiography).&#xD;
  &#xD;
           10. Echocardiographic evidence of intracardiac mass, thrombus, vegetation, or mitral valve&#xD;
               orifice area (MVOA) 4.0 cm2, or any condition unsuitable for the study device,&#xD;
               including but not limited to:&#xD;
  &#xD;
                 1. Unsuitable for leaflet capture due to severe calcification or cleft.&#xD;
  &#xD;
                 2. Lack of primary and secondary chordal support in the capture area.&#xD;
  &#xD;
                 3. Leaflet free edge length &lt; 0.8 cm.&#xD;
  &#xD;
           11. Known conditions that preclude study procedure (including but not limited to allergies&#xD;
               to device components, coagulation disorders, life expectancy &lt; 1 year).&#xD;
  &#xD;
           12. Pregnant or breastfeeding women or those planning pregnancy during the trial period.&#xD;
  &#xD;
           13. Intending or currently participating in another interventional clinical trial.&#xD;
  &#xD;
           14. Other conditions deemed inappropriate for participation in this study by the&#xD;
               investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Beijing Anzhen Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>transcatheter edge-to-edge repair</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mitral Valve Insufficiency</mesh_term>
    </condition_browse>
    <!-- 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/NCT06021509
  org study id: YM-2022-001
  nct id: NCT06021509
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To validate the safety and efficacy of transcatheter edge-to-edge repair (TEER) using the
        NovoClasp® transcatheter mitral valve clip and steerable guide catheter in the treatment of
        moderate to severe and severe degenerative mitral regurgitation (DMR).
  This trial is a prospective multi-center single-arm confirmatory study. A total of 102
        subjects will be enrolled in multiple centers nationwide. Subjects who meet the trial
        requirements, fulfill the inclusion criteria, voluntarily participate in the study, and
        provide informed consent will undergo mitral edge-to-edge repair using the NovoClasp®
        transcatheter mitral valve clip system and steerable guide catheter for the treatment of
        moderate to severe or severe degenerative mitral regurgitation (DMR). Follow-up assessments
        will be conducted at discharge, as well as at 30 days, 90 days, 180 days, and 360 days
        postoperatively. The primary endpoint will be the treatment effectiveness rate at 360 days
        post-surgery. Secondary endpoint measures include treatment effectiveness at other time
        points, surgical success rate, all-cause mortality, device/procedure-related mortality,
        incidence of adverse events, and serious adverse event rates. The trial aims to
        comprehensively assess the safety and efficacy of the NovoClasp® transcatheter mitral valve
        clip and steerable guide catheter produced by Enlight Medical Technologies (Shanghai) Co.,
        Ltd..
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Treatment effectiveness rate
  time frame: 1 year
  description: Treatment effectiveness is defined as the success of the procedure with the mitral valve regurgitation sustained at moderate or lower (<=2+) after the surgery, without major adverse events or secondary interventions (interventional or surgical).
  measure: Procedural success rate
  time frame: immediately after procedure
  description: Successful implantation of a single device as intended by the operator, successful retrieval of the delivery system, absence of device migration, dislodgment, embolization, related complications, or other unforeseen incidents.
  measure: Procedural success rate
  time frame: During the perioperative period
  description: Defined as successful completion of the investigational procedure as intended by the operator (implantation of at least 1 study device) and reduction of mitral valve regurgitation to moderate or below (<=2+), without open surgery, major adverse events during the perioperative period, or secondary interventions (interventional or surgical).
  Note: Major adverse events include cardiovascular-related deaths, stroke, myocardial infarction, need for renal replacement therapy, severe bleeding (hemoglobin decrease >=3g/dL compared to baseline, or requiring >=3 units of blood transfusion), or organ damage, failure, or death dur to blood loss.
  measure: Rate of Treatment success
  time frame: 30 days, 180 days
  description: Treatment effectiveness is defined as the success of the procedure with the mitral valve regurgitation sustained at moderate or lower (<=2+) after the surgery, without major adverse events or secondary interventions (interventional or surgical).
  measure: Changes in New York Heart Association (NYHA) Functional Classification
  time frame: through study completiong, an average of 1 year.
  description: The NYHA Classification provides nomenclature to describe an overall cardiac appraisal of the status of a patient with heart disease.
  Class I: Patients with cardiac disease but without resulting limitation of physical activity.
  Class II: patients with cardiac disease resulting in slight limitation of physical activity.
  Class III: Patients with cardiac disease resulting in marked limitation of physical activity.
  Class IV: Patient with cardiac disease resulting in inability to carry on any physical activity without discomfor.
  measure: All cause mortality
  time frame: through study completion, an average of 1 year
  measure: Device/Procedure-related mortality
  time frame: through study completion, an average of 1 year
  measure: Major adverse events
  time frame: through study completion, an average of 1 year
  measure: Serious adverse events
  time frame: through study completion, an average of 1 year
  measure: Number of participants with device-related adverse events
  time frame: through study completion, an average of 1 year
  arm group label: NovoClasp system
  arm group type: Experimental
  intervention type: Device
  intervention name: NovoClasp® transcatheter mitral valve clip and steerable guide catheter
  description: The experimental device is a class III implanted valve device, which will be used to treat the mitral valve regurgitation via transcatheter edge-to-edge repair.
  arm group label: NovoClasp system
  other name: transcatheter edge-to-edge repair for mitral valve
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Mitral Valve Insufficiency