<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/NCT03024268</url>
  </required_header>
  <id_info>
    <org_study_id>MITHRAS</org_study_id>
    <nct_id>NCT03024268</nct_id>
  </id_info>
  <brief_title>MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure</brief_title>
  <official_title>MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure - Evaluation of Morphologic and Functional Changes in a Randomized Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heart Center Leipzig - University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heart Center Leipzig - University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure&#xD;
      caused iatrogenic arterial septal defect (iASD) and the functional changes after&#xD;
      interventional iASD closure in a randomized setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transcatheter mitral valve repair with the MitraClip system is a therapeutic alternative to&#xD;
      surgery in selected high-risk patients. Clip placement requires interatrial transseptal&#xD;
      puncture and meticulous manipulation of the steerable sheath. There is evidence that the&#xD;
      persistence of a relevant iASD after MitraClip is associated with worse clinical outcomes and&#xD;
      increased mortality.&#xD;
&#xD;
      The purpose of this study is to investigate, if the interventional closure of an persistant&#xD;
      hemodynamic relevant iASD 30 days after MitraClip implantation, has favorable effects on&#xD;
      clinical outcome. Eligible patients, after obtaining written informed consent, are 1:1&#xD;
      randomized either in group A (interventional occlusion of iASD) or group B (best supportive&#xD;
      care).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Actual">September 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Exercise tolerance: 6 minute walking test</measure>
    <time_frame>baseline, 3 and 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in New York Heart Association Functional Classification assessment</measure>
    <time_frame>baseline, 3 and 6 months</time_frame>
    <description>Changes in New York Heart Association Functional Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Echocardiography: bi ventricular function (2D and 3D)</measure>
    <time_frame>baseline, 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Echocardiography: assessment of left atrium (2D and 3D)</measure>
    <time_frame>baseline, 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Echocardiography: assessment of heart valves</measure>
    <time_frame>baseline, 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Echocardiography: strain using speckle tracking</measure>
    <time_frame>baseline, 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D)</measure>
    <time_frame>baseline, 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart insufficiency bio markers</measure>
    <time_frame>baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Cardiac MRI: bi ventricular function</measure>
    <time_frame>baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Cardiac MRI: left ventricular longitudinal strain</measure>
    <time_frame>baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Cardiac MRI: left ventricular circumferential strain</measure>
    <time_frame>baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta</measure>
    <time_frame>baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of hospitalisation rate</measure>
    <time_frame>baseline, 3, 6 and 12 months</time_frame>
    <description>Telephone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of mortality</measure>
    <time_frame>baseline, 3, 6 and 12 months</time_frame>
    <description>Telephone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combined endpoint (hospitalisation and mortality)</measure>
    <time_frame>baseline, 3, 6 and 12 months</time_frame>
    <description>Telephone; Combined Endpoint of hospitalisation and mortality. For analysis the first event is counted regardless of severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life in &quot;Minnesota Living with Heart Failure&quot; questionnaire</measure>
    <time_frame>baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life in &quot;Short Form - 36&quot; questionnaire</measure>
    <time_frame>baseline and 6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Acute changes in right and left ventricular pressures during interventionell ASD closure</measure>
    <time_frame>immediately before and immediately after ASD closure</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Mitral Valve Insufficiency</condition>
  <condition>Heart Septal Defects, Atrial</condition>
  <arm_group>
    <arm_group_label>A: interventional closure of iASD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B: no intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Best medical supportive care (n=40)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Figulla Flex Occluder (Occlutech)</intervention_name>
    <description>Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech)</description>
    <arm_group_label>A: interventional closure of iASD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Previous MitraClip implantation&#xD;
&#xD;
          -  Persistent relevant iASD 30 days after MitraClip intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unsuccessful MitraClip implantation&#xD;
&#xD;
          -  No relevant iASD 30 days after MitraClip intervention&#xD;
&#xD;
          -  Unstable angina in the previous 4 weeks&#xD;
&#xD;
          -  Valvular heart disease (aortic, tricuspid or pulmonary valve) planed for surgery or&#xD;
             interventional therapy&#xD;
&#xD;
          -  Constrictive pericarditis / restrictive cardiomyopathies&#xD;
&#xD;
          -  Pericardial effusion planed for surgery or interventional therapy&#xD;
&#xD;
          -  Coagulation disorders&#xD;
&#xD;
          -  Malignant disease with a life expectance &lt; 12 months&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Participation in another study&#xD;
&#xD;
          -  iASD diameter &gt; 38 mm&#xD;
&#xD;
          -  Aortic minimum distance of the iASD &lt; 5 mm&#xD;
&#xD;
          -  Thrombus in left atrial appendage&#xD;
&#xD;
          -  Venous access impossible with a 24 French catheter system&#xD;
&#xD;
          -  Presence of an inferior vena cava filter&#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, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart Center of the University Leipzig</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephan Blazek, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Heart Center of the University Leipzig</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Center of the University Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heart Center Leipzig - University Hospital</investigator_affiliation>
    <investigator_full_name>Philipp Lurz</investigator_full_name>
    <investigator_title>Clinical Investigator, Professor, Managing Senior Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Septal Defects</mesh_term>
    <mesh_term>Mitral Valve Insufficiency</mesh_term>
    <mesh_term>Heart Septal Defects, Atrial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03024268
org study id: MITHRAS
nct id: NCT03024268
lead sponsor: 
has dmc: No
Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure
      caused iatrogenic arterial septal defect (iASD) and the functional changes after
      interventional iASD closure in a randomized setting.
Transcatheter mitral valve repair with the MitraClip system is a therapeutic alternative to
      surgery in selected high-risk patients. Clip placement requires interatrial transseptal
      puncture and meticulous manipulation of the steerable sheath. There is evidence that the
      persistence of a relevant iASD after MitraClip is associated with worse clinical outcomes and
      increased mortality.

      The purpose of this study is to investigate, if the interventional closure of an persistant
      hemodynamic relevant iASD 30 days after MitraClip implantation, has favorable effects on
      clinical outcome. Eligible patients, after obtaining written informed consent, are 1:1
      randomized either in group A (interventional occlusion of iASD) or group B (best supportive
      care).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Exercise tolerance: 6 minute walking test
time frame: baseline, 3 and 6 months
measure: Change in New York Heart Association Functional Classification assessment
time frame: baseline, 3 and 6 months
description: Changes in New York Heart Association Functional Classification
measure: Changes in Echocardiography: bi ventricular function (2D and 3D)
time frame: baseline, 3 and 6 months
measure: Changes in Echocardiography: assessment of left atrium (2D and 3D)
time frame: baseline, 3 and 6 months
measure: Changes in Echocardiography: assessment of heart valves
time frame: baseline, 3 and 6 months
measure: Changes in Echocardiography: strain using speckle tracking
time frame: baseline, 3 and 6 months
measure: Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D)
time frame: baseline, 3 and 6 months
measure: Heart insufficiency bio markers
time frame: baseline and 6 months
measure: Changes in Cardiac MRI: bi ventricular function
time frame: baseline and 6 months
measure: Changes in Cardiac MRI: left ventricular longitudinal strain
time frame: baseline and 6 months
measure: Changes in Cardiac MRI: left ventricular circumferential strain
time frame: baseline and 6 months
measure: Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta
time frame: baseline and 6 months
measure: Evaluation of hospitalisation rate
time frame: baseline, 3, 6 and 12 months
description: Telephone
measure: Evaluation of mortality
time frame: baseline, 3, 6 and 12 months
description: Telephone
measure: Combined endpoint (hospitalisation and mortality)
time frame: baseline, 3, 6 and 12 months
description: Telephone; Combined Endpoint of hospitalisation and mortality. For analysis the first event is counted regardless of severity.
measure: Changes in quality of life in "Minnesota Living with Heart Failure" questionnaire
time frame: baseline and 6 months
measure: Changes in quality of life in "Short Form - 36" questionnaire
time frame: baseline and 6 months
measure: Acute changes in right and left ventricular pressures during interventionell ASD closure
time frame: immediately before and immediately after ASD closure
arm group label: A: interventional closure of iASD
arm group type: Experimental
description: Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech)
arm group label: B: no intervention
arm group type: No Intervention
description: Best medical supportive care (n=40)
intervention type: Device
intervention name: Figulla Flex Occluder (Occlutech)
description: Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech)
arm group label: A: interventional closure of iASD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philipp Lurz, MD, PhD
role: Principal Investigator
affiliation: Heart Center of the University Leipzig
last name: Stephan Blazek, MD
role: Study Chair
affiliation: Heart Center of the University Leipzig
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heart Center Leipzig - University Hospital
investigator full name: Philipp Lurz
investigator title: Clinical Investigator, Professor, Managing Senior Physician
mesh term: Heart Septal Defects
mesh term: Mitral Valve Insufficiency
mesh term: Heart Septal Defects, Atrial
sharing ipd: Undecided