<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/NCT03230747</url>
  </required_header>
  <id_info>
    <org_study_id>2017-03</org_study_id>
    <nct_id>NCT03230747</nct_id>
  </id_info>
  <brief_title>SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation</brief_title>
  <acronym>SAPIEN M3 EFS</acronym>
  <official_title>Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Edwards Lifesciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety and functionality of the SAPIEN M3 System in patients&#xD;
      with symptomatic, severe MR and will provide guidance for future clinical study designs&#xD;
      utilizing the SAPIEN M3 System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, single-arm, multicenter early feasibility study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Anticipated">August 2027</completion_date>
  <primary_completion_date type="Actual">June 16, 2021</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>Technical Success</measure>
    <time_frame>At the end of the procedure</time_frame>
    <description>Defined as meeting all the following:&#xD;
Alive&#xD;
Successful access, delivery and retrieval of the delivery systems&#xD;
Deployment of the devices in the intended position&#xD;
Freedom from emergency surgery or reintervention related to the device or access procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in mitral regurgitation (MR)</measure>
    <time_frame>30 Days</time_frame>
    <description>Reduction in MR to 0 or 1+</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Mitral Regurgitation</condition>
  <condition>Mitral Disease</condition>
  <arm_group>
    <arm_group_label>TMVR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will undergo transcatheter mitral valve replacement</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Edwards SAPIEN M3 System</intervention_name>
    <description>SAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock</description>
    <arm_group_label>TMVR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. MR ≥ 3+&#xD;
&#xD;
          3. NYHA functional class ≥ II&#xD;
&#xD;
          4. High risk of cardiovascular surgery&#xD;
&#xD;
          5. Hemodynamically stable while on heart failure medication for at least 2 weeks before&#xD;
             the procedure&#xD;
&#xD;
          6. The study patient has been informed of the nature of the study, agrees to its&#xD;
             provisions and has provided written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mitral anatomy that would preclude appropriate delivery and deployment of the dock or&#xD;
             valve&#xD;
&#xD;
          2. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation&#xD;
&#xD;
          3. Significant risk of LVOT obstruction&#xD;
&#xD;
          4. Severe right ventricular dysfunction&#xD;
&#xD;
          5. LV Ejection Fraction &lt;30%&#xD;
&#xD;
          6. Patient is inoperable&#xD;
&#xD;
          7. Prior surgical or interventional treatment of mitral valve preventing appropriate&#xD;
             device access and deployment&#xD;
&#xD;
          8. Need for aortic, tricuspid or pulmonic valve replacement&#xD;
&#xD;
          9. Presence of mechanical aortic valve prosthesis&#xD;
&#xD;
         10. History of cardiac transplantation&#xD;
&#xD;
         11. History of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism&#xD;
&#xD;
         12. Clinically significant untreated coronary artery disease requiring revascularization&#xD;
&#xD;
         13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid&#xD;
             surgery within 30 days.&#xD;
&#xD;
         14. Stroke or transient ischemic attack within 90 days of the procedure&#xD;
&#xD;
         15. Myocardial infarction within 30 days of the procedure&#xD;
&#xD;
         16. Active bacterial endocarditis within 180 days of the procedure&#xD;
&#xD;
         17. Inability to tolerate or a medical condition precluding treatment with anti-thrombotic&#xD;
             therapy&#xD;
&#xD;
         18. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy,&#xD;
             or hypercoagulable states&#xD;
&#xD;
         19. Hospitalization for CHF or hemodynamic instability requiring inotropic support or&#xD;
             intra-aortic balloon pump within 30 days.&#xD;
&#xD;
         20. Irreversible, severe pulmonary hypertension&#xD;
&#xD;
         21. Patients with renal insufficiency or receiving renal replacement therapy&#xD;
&#xD;
         22. Liver disease or significantly abnormal liver function test results&#xD;
&#xD;
         23. Refusal of blood products&#xD;
&#xD;
         24. Female who is pregnant or lactating&#xD;
&#xD;
         25. Estimated life expectancy &lt; 12 months&#xD;
&#xD;
         26. Participating in another investigational drug or device study&#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>Cedars-Sinai Medical Center Heart Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evanston/ Northshore University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Cardiovascular Research Institution</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V62146</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transcatheter Mitral Valve Replacement</keyword>
  <keyword>SAPIEN M3</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>


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/NCT03230747
org study id: 2017-03
nct id: NCT03230747
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients
      with symptomatic, severe MR and will provide guidance for future clinical study designs
      utilizing the SAPIEN M3 System.
Prospective, single-arm, multicenter early feasibility study
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Technical Success
time frame: At the end of the procedure
description: Defined as meeting all the following:
Alive
Successful access, delivery and retrieval of the delivery systems
Deployment of the devices in the intended position
Freedom from emergency surgery or reintervention related to the device or access procedure
measure: Reduction in mitral regurgitation (MR)
time frame: 30 Days
description: Reduction in MR to 0 or 1+
arm group label: TMVR
arm group type: Experimental
description: Subjects will undergo transcatheter mitral valve replacement
intervention type: Device
intervention name: Edwards SAPIEN M3 System
description: SAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock
arm group label: TMVR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency
sharing ipd: No