<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/NCT04473092</url>
  </required_header>
  <id_info>
    <org_study_id>20-9223-BO</org_study_id>
    <nct_id>NCT04473092</nct_id>
  </id_info>
  <brief_title>Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort</brief_title>
  <acronym>OneForAll</acronym>
  <official_title>Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Essen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To identify changes on mitral valve morphology and functionality by the application of the&#xD;
      PascalTM in MR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transcatheter mitral valve repair (TMVR) in mitral regurgitation (MR) is increasingly applied&#xD;
      in patients on high surgical risk. Interventional mitral valve repair can be applied is&#xD;
      routinely applied in primary and secondary mitral regurgitation. While the edge-to-edge&#xD;
      technique has been the solely available technlology in the marked for the last years, the&#xD;
      recently introduced PascalTM technology represents a novel concept and is characterized by a&#xD;
      central spacer, wider paddles, and larger dimensions. Implications of implantation of the&#xD;
      PascalTM device on the mitral valve morphology and functionality concerning potential changes&#xD;
      on mitral regurgitation as well as changes on mitral valve orifice area are to date not fully&#xD;
      understood. The current study will identify anatomical changes to optimize ideal patient&#xD;
      selection and optimal treatment approaches of the PASCALTM device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 20, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Morphologic and functional changes of mitral valve anatomy</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Mitral Regurgitation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TMVR</intervention_name>
    <description>Patients who undergo TMVR for MR at the PI´s site</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who undergo TVMR for MR (age &gt;18yrs) at the PI´s site&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • All patients who undergo TVMR for MR (age &gt;18yrs) at the PI´s site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18yry&#xD;
&#xD;
          -  Subject does not provide full consent&#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>Peter Lüdike, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Essen, Westgerman Heart- and Vascular Center, Department of Cardiology and Vascular Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Essen, Westgerman Heart and Vascular Center, Department of Cardiology and Vascular Medicine</name>
      <address>
        <city>Essen</city>
        <state>NRW</state>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Essen</investigator_affiliation>
    <investigator_full_name>Peter Lüdike</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <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/NCT04473092
org study id: 20-9223-BO
nct id: NCT04473092
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To identify changes on mitral valve morphology and functionality by the application of the
      PascalTM in MR.
Transcatheter mitral valve repair (TMVR) in mitral regurgitation (MR) is increasingly applied
      in patients on high surgical risk. Interventional mitral valve repair can be applied is
      routinely applied in primary and secondary mitral regurgitation. While the edge-to-edge
      technique has been the solely available technlology in the marked for the last years, the
      recently introduced PascalTM technology represents a novel concept and is characterized by a
      central spacer, wider paddles, and larger dimensions. Implications of implantation of the
      PascalTM device on the mitral valve morphology and functionality concerning potential changes
      on mitral regurgitation as well as changes on mitral valve orifice area are to date not fully
      understood. The current study will identify anatomical changes to optimize ideal patient
      selection and optimal treatment approaches of the PASCALTM device.
observational model: Case-Control
time perspective: Prospective
measure: Morphologic and functional changes of mitral valve anatomy
time frame: 1 year
intervention type: Device
intervention name: TMVR
description: Patients who undergo TMVR for MR at the PI´s site
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Lüdike, MD
role: Principal Investigator
affiliation: University Hospital Essen, Westgerman Heart- and Vascular Center, Department of Cardiology and Vascular Medicine
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Essen
investigator full name: Peter Lüdike
investigator title: Prof. Dr.
mesh term: Mitral Valve Insufficiency
sharing ipd: No