<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/NCT04443218</url>
  </required_header>
  <id_info>
    <org_study_id>2019-03</org_study_id>
    <nct_id>NCT04443218</nct_id>
  </id_info>
  <brief_title>Edwards PASCAL Transcatheter Valve Repair System Registry</brief_title>
  <acronym>PASCALRegistry</acronym>
  <official_title>Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System</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>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>
      This registry will collect prospective and retrospective clinical data on patients treated&#xD;
      with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post Market Clinical&#xD;
      Follow-up (PMCF) study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients treated per standard of care at their medical facilities and a written informed&#xD;
      consent will be collected to allow the data to be collected. This registry intends to enroll&#xD;
      patients under commercial usage and will serve as a mechanism to collect clinical data to&#xD;
      further characterize the safety, performance and effectiveness of the PASCAL Transcatheter&#xD;
      Valve Repair System.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 27, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Major Adverse Events (MAEs)</measure>
    <time_frame>30 days</time_frame>
    <description>Rates of Major Adverse Events (MAE) at 30 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mitral Regurgitation Change</measure>
    <time_frame>30 days</time_frame>
    <description>Change in severity of mitral regurgitation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mitral Regurgitation Change</measure>
    <time_frame>12 months</time_frame>
    <description>Change in severity of mitral regurgitation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life - KCCQ</measure>
    <time_frame>30 days</time_frame>
    <description>Change in Quality of Life as assessed by KCCQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life - KCCQ</measure>
    <time_frame>12 months</time_frame>
    <description>Change in Quality of Life as assessed by KCCQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life - EuroQol Group EQ-5D</measure>
    <time_frame>30 days</time_frame>
    <description>Change in Quality of Life as assessed by EuroQol Group EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life - EuroQol Group EQ-5D</measure>
    <time_frame>12 months</time_frame>
    <description>CHange in Quality of Life as assessed by EuroQol Group EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association scale</measure>
    <time_frame>30 days</time_frame>
    <description>Change in NYHA scale rated from I-IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association scale</measure>
    <time_frame>12 months</time_frame>
    <description>Change in NYHA scale rated from I-IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Minute Walk test</measure>
    <time_frame>30 days</time_frame>
    <description>Change in distance in meters in the 6 minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Minute Walk test</measure>
    <time_frame>12 months</time_frame>
    <description>Change in distance in meters in the 6 minute walk test</description>
  </secondary_outcome>
  <enrollment type="Actual">220</enrollment>
  <condition>Mitral Valve Insufficiency</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Edwards PASCAL Transcatheter Valve Repair System</intervention_name>
    <description>The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient mitral valve.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Mitral Regurgitation eligible to receive the PASCAL device&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient signs informed consent to participate in the registry&#xD;
&#xD;
          -  Patient is intended to or has received the PASCAL device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient does not consent to participate&#xD;
&#xD;
          -  Patient is part of an ongoing Edwards Pre or Post Market Clinical study for the PASCAL&#xD;
             Transcatheter Valve Repair System.&#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>Joerg Hausleiter, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>MD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LMU Klinikum der Universität München</name>
      <address>
        <city>München</city>
        <state>Bavaria</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Immanuel Klinikum Bernau</name>
      <address>
        <city>Bernau</city>
        <state>Brandenburg</state>
        <zip>16321</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Gießen</name>
      <address>
        <city>Gießen</city>
        <state>Hesse</state>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georg-August-Universität Göttingen, Universitätsmedizin Göttingen</name>
      <address>
        <city>Göttingen</city>
        <state>Lower Saxony</state>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Köln</name>
      <address>
        <city>Cologne</city>
        <state>Nord Rhine Westphalia</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW - Bad Oeynhausen</name>
      <address>
        <city>Bad Oeynhausen</city>
        <state>North Rhine Westphalia</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum der Universitätsklinik Bonn</name>
      <address>
        <city>Bonn</city>
        <state>North Rhine Westphalia</state>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.-Johannes-Hospital Dortmund</name>
      <address>
        <city>Dortmund</city>
        <state>North Rhine Westphalia</state>
        <zip>44137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elisabeth-Krankenhaus Essen</name>
      <address>
        <city>Essen</city>
        <state>North Rhine Westphalia</state>
        <zip>45138</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Johannes Gutenberg Universität Mainz</name>
      <address>
        <city>Mainz</city>
        <state>Rhineland-Palatinate</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Universitätsklinik Dresden</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Centre of the University Leipzig</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kath. Marienkrankenhaus Hamburg GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>22087</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</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>Mitral Valve Insufficiency</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 12, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04443218
org study id: 2019-03
nct id: NCT04443218
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This registry will collect prospective and retrospective clinical data on patients treated
      with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post Market Clinical
      Follow-up (PMCF) study.
Patients treated per standard of care at their medical facilities and a written informed
      consent will be collected to allow the data to be collected. This registry intends to enroll
      patients under commercial usage and will serve as a mechanism to collect clinical data to
      further characterize the safety, performance and effectiveness of the PASCAL Transcatheter
      Valve Repair System.
observational model: Cohort
time perspective: Other
measure: Major Adverse Events (MAEs)
time frame: 30 days
description: Rates of Major Adverse Events (MAE) at 30 days.
measure: Mitral Regurgitation Change
time frame: 30 days
description: Change in severity of mitral regurgitation
measure: Mitral Regurgitation Change
time frame: 12 months
description: Change in severity of mitral regurgitation
measure: Change in Quality of Life - KCCQ
time frame: 30 days
description: Change in Quality of Life as assessed by KCCQ
measure: Change in Quality of Life - KCCQ
time frame: 12 months
description: Change in Quality of Life as assessed by KCCQ
measure: Change in Quality of Life - EuroQol Group EQ-5D
time frame: 30 days
description: Change in Quality of Life as assessed by EuroQol Group EQ-5D
measure: Change in Quality of Life - EuroQol Group EQ-5D
time frame: 12 months
description: CHange in Quality of Life as assessed by EuroQol Group EQ-5D
measure: New York Heart Association scale
time frame: 30 days
description: Change in NYHA scale rated from I-IV
measure: New York Heart Association scale
time frame: 12 months
description: Change in NYHA scale rated from I-IV
measure: 6 Minute Walk test
time frame: 30 days
description: Change in distance in meters in the 6 minute walk test
measure: 6 Minute Walk test
time frame: 12 months
description: Change in distance in meters in the 6 minute walk test
intervention type: Device
intervention name: Edwards PASCAL Transcatheter Valve Repair System
description: The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient mitral valve.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joerg Hausleiter, Prof.
role: Principal Investigator
affiliation: MD
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Switzerland
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency
submitted: May 12, 2023