<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/NCT04430075</url>
  </required_header>
  <id_info>
    <org_study_id>2018-08</org_study_id>
    <nct_id>NCT04430075</nct_id>
  </id_info>
  <brief_title>MiCLASP Post Market Clinical Follow-Up (PMCF) Study</brief_title>
  <acronym>MiCLASP</acronym>
  <official_title>Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)</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>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards&#xD;
      PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve&#xD;
      Repair System in transcatheter mitral valve repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL&#xD;
      Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair&#xD;
      System in transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL&#xD;
      System and Edwards PASCAL Precision System in improving MR, functional status and quality of&#xD;
      life in a post market setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 23, 2019</start_date>
  <completion_date type="Anticipated">February 2029</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with major adverse events (MAE rates)</measure>
    <time_frame>30 days</time_frame>
    <description>The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mitral regurgitation severity (scale of 0-4+) by echocardiography</measure>
    <time_frame>Discharge: defined as discharge or 7 days post-procedure, whichever comes first</time_frame>
    <description>Mitral regurgitation severity will be assessed by echocardiography at timepoint discharge on a scale from 0-4+ and compared to timepoint baseline Mitral regurgitation severity</description>
  </primary_outcome>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Mitral Regurgitation</condition>
  <condition>Mitral Insufficiency</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System</intervention_name>
    <description>Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at or over the age of 18 determined to require percutaneous reconstruction of an&#xD;
        insufficient mitral valve [MR ≥ 2+ (PASCAL patients) or MR ≥ 3+ (PASCAL Precision&#xD;
        patients)] by a Heart Team who assesses patient risk and anatomic suitability should be&#xD;
        considered for inclusion in this trial.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Patient is determined to require percutaneous reconstruction of an insufficient mitral&#xD;
             valve [MR grade ≥2+ (PASCAL System patients only) or MR grade ≥3+ (PASCAL Precision&#xD;
             System patients only)] by a Heart Team who assesses patient risk and anatomic&#xD;
             suitability.&#xD;
&#xD;
          -  Patient is eligible to receive the PASCAL or PASCAL Precision device per the current&#xD;
             approved indications for use.&#xD;
&#xD;
          -  Minimum 6 minutes walk test of 150m. This criteria applies only to patients presenting&#xD;
             with primarily functional mitral valve regurgitation.&#xD;
&#xD;
          -  Patient is willing and able to attend all follow-up visits and to perform all tests.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient in whom a transesophageal echocardiography is contraindicated or screening&#xD;
             transesophageal echocardiography is unsuccessful&#xD;
&#xD;
          -  Leaflet anatomy which may preclude PASCAL or PASCAL Precision device implantation,&#xD;
             proper device positioning on the leaflets, or sufficient reduction in mitral&#xD;
             regurgitation&#xD;
&#xD;
          -  Echocardiographic evidence of intracardiac mass, thrombus, or vegetation&#xD;
&#xD;
          -  LVEDD &gt; 8.0 cm determined by transthoracic echocardiography within 60 days prior to&#xD;
             submission&#xD;
&#xD;
          -  Contraindication to transseptal catheterization&#xD;
&#xD;
          -  Presence of an occluded or thrombosed Inferior vena cava filter that would interfere&#xD;
             with the delivery catheter, or ipsilateral deep vein thrombosis is present.&#xD;
&#xD;
          -  Known hypersensitivity to nitinol or contraindication to procedural medications which&#xD;
             cannot be adequately managed medically&#xD;
&#xD;
          -  Mitral valve area (MVA) &lt; 4.0 cm² as measured by planimetry (If MVA by planimetry is&#xD;
             not measurable, PHT measurement is acceptable)&#xD;
&#xD;
          -  Concurrent medical condition with a life expectancy of less than 12 months in the&#xD;
             judgment of the Investigator&#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>Philipp Lurz, Prof.Dr.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart Centre of the University Leipzig</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>TMTT Clinical Affairs</last_name>
    <phone>+1 (949) 250</phone>
    <phone_ext>2500</phone_ext>
    <email>TMTT_Clinical@edwards.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medizinische Universität Wien/AKH Wien</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medizinische Klinik I- Campus Grosshadern</name>
      <address>
        <city>München</city>
        <state>Bavaria</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jörg Hausleiter, Prof.Dr.</last_name>
      <email>joerg.hausleiter@med.uni-muenchen.de</email>
    </contact>
    <investigator>
      <last_name>Jörg Hausleiter, Prof.Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Immanuel Klinikum Bernau</name>
      <address>
        <city>Bernau</city>
        <state>Brandenburg</state>
        <zip>16321</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Giessen UKGM</name>
      <address>
        <city>Gießen</city>
        <state>Hessen</state>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Holger Nef, Prof.Dr.</last_name>
      <email>Holger.Nef@innere.med.uni-giessen.de</email>
    </contact>
    <investigator>
      <last_name>Holger Nef, Prof.Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitaeres Herzzentrum Goettingen</name>
      <address>
        <city>Göttingen</city>
        <state>Lower Saxony</state>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen</name>
      <address>
        <city>Essen</city>
        <state>Nordrhine Westfalia</state>
        <zip>45138</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Schmitz, Dr.</last_name>
      <email>t.schmitz@contilia.de</email>
    </contact>
    <investigator>
      <last_name>Thomas Schmitz, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <state>North Rhine-Westphalia</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Georg Nickenig, Prof.Dr.</last_name>
      <email>georg.nickenig@ukb.uni-bonn.de</email>
    </contact>
    <investigator>
      <last_name>Georg Nickenig, Prof.Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St.-Johannes-Hospital</name>
      <address>
        <city>Dortmund</city>
        <state>North Rhine-Westphalia</state>
        <zip>44137</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Johannes Gutenberg Universität Mainz</name>
      <address>
        <city>Mainz</city>
        <state>North Rhine-Westphalia</state>
        <zip>55313</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Universitätsklinik Dresden</name>
      <address>
        <city>Dresden</city>
        <state>Saxonia</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein</name>
      <address>
        <city>Lübeck</city>
        <state>Schleswig-Holstein</state>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW - Bad Oeynhausen</name>
      <address>
        <city>Bad Oeynhausen</city>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Volker Rudolph, Prof.Dr.</last_name>
      <email>vrudolph@hdz-nrw.de</email>
    </contact>
    <investigator>
      <last_name>Volker Rudolph, Prof.Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charité Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne</name>
      <address>
        <city>Cologne</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Westdeutsches Herzzentrum / Uniklinik Essen</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Lüdicke, Dr.</last_name>
      <email>peter.luedike@uk-essen.de</email>
    </contact>
    <investigator>
      <last_name>Peter Lüdicke, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kath. Marienkrankenhaus Hamburg GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>22087</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edith Lubos, Dr.</last_name>
      <email>e.lubos@marienkrankenhaus.org</email>
    </contact>
    <investigator>
      <last_name>Edith Lubos, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Heart Centre of the University Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philipp Lurz, Prof.Dr.</last_name>
      <email>philipp.lurz@medizin.uni-leipzig.de</email>
    </contact>
    <investigator>
      <last_name>Philipp Lurz, Prof.Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Helios Klinikum Siegburg</name>
      <address>
        <city>Siegburg</city>
        <zip>53721</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universität Tuebingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tobias Geisler, Prof.Dr.</last_name>
      <email>Tobias.Geisler@med.uni-tuebingen.de</email>
    </contact>
    <investigator>
      <last_name>Tobias Geisler, Prof.Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Uniklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wolfgang Rottbauer, Prof.</last_name>
      <email>sekretariat.rottbauer@uniklinik-ulm.de</email>
    </contact>
    <investigator>
      <last_name>Wolfgang Rottbauer, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hygeia Hospital</name>
      <address>
        <city>Athens</city>
        <zip>151 23</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <state>Lombardy</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale del Cuore G. Pasquinucci Massa</name>
      <address>
        <city>Massa</city>
        <zip>54100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3435</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Cardinal Stefan Wyszyński, Institute of Cardiology</name>
      <address>
        <city>Warsaw</city>
        <zip>04-628</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Alvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <zip>36213</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wythenshawe Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 19, 2019</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 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>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/NCT04430075
org study id: 2018-08
nct id: NCT04430075
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards
      PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve
      Repair System in transcatheter mitral valve repair.
The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL
      Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair
      System in transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL
      System and Edwards PASCAL Precision System in improving MR, functional status and quality of
      life in a post market setting.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with major adverse events (MAE rates)
time frame: 30 days
description: The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
measure: Change in mitral regurgitation severity (scale of 0-4+) by echocardiography
time frame: Discharge: defined as discharge or 7 days post-procedure, whichever comes first
description: Mitral regurgitation severity will be assessed by echocardiography at timepoint discharge on a scale from 0-4+ and compared to timepoint baseline Mitral regurgitation severity
intervention type: Device
intervention name: Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
description: Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philipp Lurz, Prof.Dr.med.
role: Principal Investigator
affiliation: Heart Centre of the University Leipzig
last name: TMTT Clinical Affairs
phone: +1 (949) 250
phone ext: 2500
email: TMTT_Clinical@edwards.com
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
country: Austria
country: Germany
country: Greece
country: Italy
country: Netherlands
country: Poland
country: Spain
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency
sharing ipd: No