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/NCT06002386</url>
    </required_header>
    <id_info>
      <org_study_id>CL-9022</org_study_id>
      <nct_id>NCT06002386</nct_id>
    </id_info>
    <brief_title>Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure</brief_title>
    <acronym>Vsling III</acronym>
    <official_title>Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cardiac Success</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cardiac Success</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>
        Prospective, multi-center, open-label clinical study of the feasibility and initial safety&#xD;
        and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced&#xD;
        left ventricular ejection fraction, associated with ventricular dilation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">October 2027</completion_date>
    <primary_completion_date type="Anticipated">October 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>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Device related Serious Adverse Events (SAE)</measure>
      <time_frame>30 days</time_frame>
      <description>Device related Serious Adverse Events (SAE) within 30 days of the procedure: any SAE that has been determined by the safety monitor to be related to the Vsling™ implantation procedure or the Vsling™ device</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>HFrEF - Heart Failure With Reduced Ejection Fraction</condition>
    <arm_group>
      <arm_group_label>Vsling device</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Vsling device implantation</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Vsling</intervention_name>
      <description>Implantable ventricular repair device</description>
      <arm_group_label>Vsling device</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age≥ 18 and &lt; 85 years&#xD;
  &#xD;
            2. Left ventricular end diastolic diameter is greater than or equal to 55mm&#xD;
  &#xD;
            3. Ejection fraction ≥20% and ≤40%&#xD;
  &#xD;
            4. FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of&#xD;
               echocardiography (via a transthoracic or transesophageal echo)&#xD;
  &#xD;
            5. End-systolic Interpapillary muscle distance ≥ 20mm&#xD;
  &#xD;
            6. NYHA class II-IVa&#xD;
  &#xD;
            7. Cardiomyopathy of ischemic or non-ischemic origins&#xD;
  &#xD;
            8. Understands the nature of the study and procedure and able to provide written informed&#xD;
               consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any evidence of structural (chordal or leaflet) mitral lesions&#xD;
  &#xD;
            2. Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion&#xD;
               in this study&#xD;
  &#xD;
            3. Prior mitral valve repair or replacement&#xD;
  &#xD;
            4. ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this&#xD;
               study&#xD;
  &#xD;
            5. Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study&#xD;
  &#xD;
            6. Anatomy that, in the opinion of the interventionalist, prevents safe passage of the&#xD;
               Vsling™ catheter(s).&#xD;
  &#xD;
            7. Severe aortic stenosis&#xD;
  &#xD;
            8. Severe, massive, or torrential tricuspid regurgitation requiring surgical or&#xD;
               transcatheter repair&#xD;
  &#xD;
            9. Known fixed pulmonary hypertension with PA systolic pressure &gt;70 mmHg not responsive&#xD;
               to vasodilator therapy&#xD;
  &#xD;
           10. ST segment elevation myocardial infarction within 30 days prior to inclusion in this&#xD;
               study&#xD;
  &#xD;
           11. Congenital heart disease (except PFO, PDA or ASD)&#xD;
  &#xD;
           12. Heart Failure due to confirmed amyloid or other restrictive cardiomyopathies&#xD;
  &#xD;
           13. Chronic renal insufficiency defined by Creatinine ≥ 3.0 mg/dL or chronic renal&#xD;
               replacement therapy&#xD;
  &#xD;
           14. Any therapeutic invasive cardiac procedure within 30 days prior to inclusion in the&#xD;
               study&#xD;
  &#xD;
           15. Any cardiac surgery, within 3 months prior to inclusion in the study&#xD;
  &#xD;
           16. Cerebrovascular Accident (CVA) within 90 days prior to inclusion in this study&#xD;
  &#xD;
           17. Thrombocytopenia (Platelet count&lt; 100,000/mm3) or thrombocytosis (Platelet count &gt;&#xD;
               750,000/mm3)&#xD;
  &#xD;
           18. Body temperature &gt;38°C within 3 days prior to index procedure&#xD;
  &#xD;
           19. Bleeding disorders or hypercoagulable state&#xD;
  &#xD;
           20. Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the&#xD;
               scheduled implant&#xD;
  &#xD;
           21. Contraindication to anticoagulants or antiplatelet agents&#xD;
  &#xD;
           22. Known allergy to stainless steel, nickel, titanium or contrast agents that cannot be&#xD;
               adequately pre-medicated&#xD;
  &#xD;
           23. Known hypersensitivity or contraindication to procedural medications which cannot be&#xD;
               adequately managed medically&#xD;
  &#xD;
           24. Currently participating in another investigational drug or device study that has not&#xD;
               completed the primary endpoint or that clinically interferes with the endpoints of&#xD;
               this study&#xD;
  &#xD;
           25. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy&#xD;
               to &lt; 12 months&#xD;
  &#xD;
           26. Co-morbid condition(s) that, in the opinion of the investigator, could limit the&#xD;
               patient's ability to participate in the study, including compliance with follow-up&#xD;
               requirements, or that could impact the scientific integrity of the study&#xD;
  &#xD;
           27. Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Iris Yadin-Herling</last_name>
      <phone>972546633352</phone>
      <email>iris.yh@cardiacsuccess.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Heart Failure</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/NCT06002386
  org study id: CL-9022
  nct id: NCT06002386
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Prospective, multi-center, open-label clinical study of the feasibility and initial safety
        and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced
        left ventricular ejection fraction, associated with ventricular dilation.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: Device related Serious Adverse Events (SAE)
  time frame: 30 days
  description: Device related Serious Adverse Events (SAE) within 30 days of the procedure: any SAE that has been determined by the safety monitor to be related to the Vsling™ implantation procedure or the Vsling™ device
  arm group label: Vsling device
  arm group type: Experimental
  description: Vsling device implantation
  intervention type: Device
  intervention name: Vsling
  description: Implantable ventricular repair device
  arm group label: Vsling device
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Iris Yadin-Herling
  phone: 972546633352
  email: iris.yh@cardiacsuccess.com
  responsible party type: Sponsor
  mesh term: Heart Failure