<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/NCT04464876</url>
  </required_header>
  <id_info>
    <org_study_id>TP-0050</org_study_id>
    <nct_id>NCT04464876</nct_id>
  </id_info>
  <brief_title>SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation</brief_title>
  <official_title>SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InnovHeart</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InnovHeart</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is a prospective, single-arm, multi-center feasibility clinical study of the&#xD;
      SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral&#xD;
      regurgitation who are not suitable for surgical treatment following Heart Team assessment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Freedom from device-related or procedure-related major adverse events</measure>
    <time_frame>30 days</time_frame>
    <description>Freedom from device-related or procedure-related major adverse events at 30 days (cardiac death, peri-procedural myocardial infarction, disabling stroke, renal failure requiring dialysis, life threatening bleeding).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction of mitral regurgitation</measure>
    <time_frame>30 days</time_frame>
    <description>Reduction of mitral regurgitation to ≤1 at 30 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Technical success</measure>
    <time_frame>Day 0</time_frame>
    <description>Technical success defined as alive patient at exit from procedure room, with all of the following:&#xD;
Successful access, delivery and retrieval of the delivery systems.&#xD;
Development and correct positioning of the bioprosthesis.&#xD;
Freedom of additional emergency surgery or re-intervention related to the device or access procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from device-related or procedure-related major adverse events</measure>
    <time_frame>30 days, 1 year, 2 years</time_frame>
    <description>Freedom from device-related or procedure-related major adverse events throughout long- term follow-up.&#xD;
Freedom from all-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from all-cause mortality</measure>
    <time_frame>30 days, 1 year, 2 years</time_frame>
    <description>Freedom from all-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients success</measure>
    <time_frame>30 days, 1 year, 2 years</time_frame>
    <description>Patients success</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>30 days, 1 year, 2 years</time_frame>
    <description>Device success</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Minute Hall Walk Test</measure>
    <time_frame>30 days, 1 year, 2 years</time_frame>
    <description>Improvement from baseline in functional status by ≥ 30 meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KCCQ</measure>
    <time_frame>30 days, 1 year, 2 years</time_frame>
    <description>Improvement from baseline in Quality of Life by ≥ 10 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NYHA functional classification</measure>
    <time_frame>30 days, 1 year, 2 years</time_frame>
    <description>Improvement from baseline by ≥ 1 functional classification.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Mitral Regurgitation</condition>
  <condition>Valve Heart Disease</condition>
  <condition>Heart Valve Diseases</condition>
  <condition>Mitral Valve Disease</condition>
  <condition>Mitral Disease</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SATURN TA TMVR Device implanted</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SATURN TA System</intervention_name>
    <description>SATURN TA TMVR Device implanted</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years or older.&#xD;
&#xD;
          2. Severe functional mitral regurgitation (≥ Grade 3+).&#xD;
&#xD;
          3. NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.&#xD;
&#xD;
          4. Treatment and compliance with optimal guideline-directed medical therapy (GDMT) for&#xD;
             heart failure for at least 30 days.&#xD;
&#xD;
          5. Not a suitable candidate for open mitral valve surgery due to high operative risk, as&#xD;
             determined by the Heart Team.&#xD;
&#xD;
          6. Able to complete quality-of-life assessment (KCCQ).&#xD;
&#xD;
        General Exclusion Criteria:&#xD;
&#xD;
          1. Excessive frailty or comorbid conditions that preclude the anticipated benefit of the&#xD;
             valve replacement.&#xD;
&#xD;
          2. Life expectancy &lt;1 yr due to noncardiac conditions.&#xD;
&#xD;
          3. Active endocarditis.&#xD;
&#xD;
          4. Active systemic infection.&#xD;
&#xD;
          5. Modified Rankin Scale ≥4 disability.&#xD;
&#xD;
          6. Hemodialysis/ chronic renal failure (eGFR &lt; 35 mL/min/m2).&#xD;
&#xD;
          7. Pulmonary arterial hypertension (fixed PAS &lt; 60mmHg). 8) COPD on home oxygen.&#xD;
&#xD;
        9) Refuses blood transfusions. 10) Documented bleeding or coagulation conditions (hypo- or&#xD;
        hyper-coagulable states).&#xD;
&#xD;
        11) Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.&#xD;
&#xD;
        12) Pregnant/ lactating. Females of childbearing age must be willing to take&#xD;
        contraceptives.&#xD;
&#xD;
        13) Participating in other investigational studies likely to confound the results or affect&#xD;
        the study.&#xD;
&#xD;
        14) Unable to consent. 15) Unable or unwilling to comply with study Follow-up. 16) Patients&#xD;
        classified as &quot;vulnerable patients&quot;.&#xD;
&#xD;
        Cardiovascular Exclusion Criteria:&#xD;
&#xD;
          1. Myocardial infarction during prior 30 days.&#xD;
&#xD;
          2. Stroke or TIA during prior 30 days.&#xD;
&#xD;
          3. Severe extracardiac arteriopathy (safety measure for extra-circulatory support if&#xD;
             surgical conversion is needed).&#xD;
&#xD;
          4. Prior mitral valve treatment (e.g. valve repair or replacement, MitraClip, etc.),&#xD;
             and/or anticipated mitral valve treatment prior to enrollment.&#xD;
&#xD;
          5. Prior surgical mechanical valve AVR.&#xD;
&#xD;
          6. Prior TAVI.&#xD;
&#xD;
          7. Need for any cardiovascular surgery or intervention (other than for MV disease) within&#xD;
             30 days.&#xD;
&#xD;
          8. CRT or ICD implanted in previous 30 days.&#xD;
&#xD;
          9. Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure &lt;90mmHg, Inotropic&#xD;
             dependent or IABP/mechanical circulatory support.&#xD;
&#xD;
         10. CABG or PCI within previous 30 days.&#xD;
&#xD;
         11. Adequately treated for cardiac condition per applicable standards, such as for&#xD;
             coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart&#xD;
             failure. No need for revascularization.&#xD;
&#xD;
         12. Prior or planned heart transplantation (UNOS status 1).&#xD;
&#xD;
         13. Physical evidence of right-sided congestive heart failure:&#xD;
&#xD;
               1. Patients with ascites.&#xD;
&#xD;
               2. Patients with anasarca (generalized edema / hydropsy).&#xD;
&#xD;
             Procedural Exclusion Criteria:&#xD;
&#xD;
         14. Chest condition that prevents transapical access.&#xD;
&#xD;
         15. Known hypersensitivity or contraindication to procedural or post-procedural medication&#xD;
             (e.g., contrast solution, anticoagulation therapy).&#xD;
&#xD;
         16. Documented hypersensitivity to nickel or titanium.&#xD;
&#xD;
        Cardiac Exclusion Criteria (evaluated by Core Labs):&#xD;
&#xD;
          1. Left ventricular EF ≤ 30% by imaging.&#xD;
&#xD;
          2. Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or&#xD;
             mass.&#xD;
&#xD;
          3. Extensive mitral flail leaflets.&#xD;
&#xD;
          4. Left ventricular thrombus, mass, or vegetation.&#xD;
&#xD;
          5. Left ventricular end-diastolic diameter &gt; 7.5 cm.&#xD;
&#xD;
          6. Severe right ventricular dysfunction.&#xD;
&#xD;
          7. Significant intracardiac shunt.&#xD;
&#xD;
          8. Anatomic ineligibility for SATURN valve as determined by the Screening Committee.&#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>Marie Steinbrink</last_name>
    <role>Study Director</role>
    <affiliation>InnovHeart</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet University Hospital of Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart And Vascular Center, Semmelweis University</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vilnius University Hospital Santaros klinikos</name>
      <address>
        <city>Vilnius</city>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Hungary</country>
    <country>Lithuania</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>March 30, 2022</last_update_submitted>
  <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</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 Diseases</mesh_term>
    <mesh_term>Mitral Valve Insufficiency</mesh_term>
    <mesh_term>Heart Valve Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04464876
org study id: TP-0050
nct id: NCT04464876
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, single-arm, multi-center feasibility clinical study of the
      SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral
      regurgitation who are not suitable for surgical treatment following Heart Team assessment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from device-related or procedure-related major adverse events
time frame: 30 days
description: Freedom from device-related or procedure-related major adverse events at 30 days (cardiac death, peri-procedural myocardial infarction, disabling stroke, renal failure requiring dialysis, life threatening bleeding).
measure: Reduction of mitral regurgitation
time frame: 30 days
description: Reduction of mitral regurgitation to ≤1 at 30 days.
measure: Technical success
time frame: Day 0
description: Technical success defined as alive patient at exit from procedure room, with all of the following:
Successful access, delivery and retrieval of the delivery systems.
Development and correct positioning of the bioprosthesis.
Freedom of additional emergency surgery or re-intervention related to the device or access procedure.
measure: Freedom from device-related or procedure-related major adverse events
time frame: 30 days, 1 year, 2 years
description: Freedom from device-related or procedure-related major adverse events throughout long- term follow-up.
Freedom from all-cause mortality
measure: Freedom from all-cause mortality
time frame: 30 days, 1 year, 2 years
description: Freedom from all-cause mortality
measure: Patients success
time frame: 30 days, 1 year, 2 years
description: Patients success
measure: Device success
time frame: 30 days, 1 year, 2 years
description: Device success
measure: 6 Minute Hall Walk Test
time frame: 30 days, 1 year, 2 years
description: Improvement from baseline in functional status by ≥ 30 meters
measure: KCCQ
time frame: 30 days, 1 year, 2 years
description: Improvement from baseline in Quality of Life by ≥ 10 points.
measure: NYHA functional classification
time frame: 30 days, 1 year, 2 years
description: Improvement from baseline by ≥ 1 functional classification.
arm group label: Treatment
arm group type: Experimental
description: SATURN TA TMVR Device implanted
intervention type: Device
intervention name: SATURN TA System
description: SATURN TA TMVR Device implanted
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie Steinbrink
role: Study Director
affiliation: InnovHeart
facility: 
facility: 
facility: 
country: Denmark
country: Hungary
country: Lithuania
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Mitral Valve Insufficiency
mesh term: Heart Valve Diseases
sharing ipd: No