<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/NCT03798015</url>
  </required_header>
  <id_info>
    <org_study_id>2018-02143; ch18Grapow3</org_study_id>
    <nct_id>NCT03798015</nct_id>
  </id_info>
  <brief_title>Neurologic Outcome After Mitral Valve Surgery</brief_title>
  <official_title>Neurologic Outcome After Mitral Valve Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      Reconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral&#xD;
      thoracotomy technique in contrast to surgical approach by sternotomy. The minimal invasive&#xD;
      approach is favourable regarding surgical trauma, length of hospital stay and amount of blood&#xD;
      loss.&#xD;
&#xD;
      This study is to investigate the neurological outcome after minimal- invasive mitral valve&#xD;
      surgery compared to open mitral valve surgery by sternotomy.&#xD;
&#xD;
      Pre-, intra- and postsurgical data from mitral valve surgery derived from the Basel mitral&#xD;
      valve registry (collected from 2009 until now) will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    resource issues on site&#xD;
  </why_stopped>
  <start_date type="Actual">February 2009</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">December 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>occurence of stroke (yes/ no) subsequent to mitral valve surgery</measure>
    <time_frame>post surgical from day of surgery until day of discharge from hospital (approx. 2 weeks)</time_frame>
    <description>assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Mitral Valve Reconstruction</condition>
  <arm_group>
    <arm_group_label>mitral valve surgery</arm_group_label>
    <description>outcome of mitral valve surgery (stroke yes or no)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mitral valve surgery</intervention_name>
    <description>assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery</description>
    <arm_group_label>mitral valve surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients undergoing a surgical mitral valve reconstruction or replacement at the University&#xD;
        Hospital Basel from 2009 until today&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  surgery for mitral valve (reconstruction or replacement) (maybe combined with surgery&#xD;
             for tricuspid valve and/ or surgery for atrial septal defects and/or patent foramen&#xD;
             ovale)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other surgical interventions then the surgical interventions mentioned in the&#xD;
             inclusion criteria&#xD;
&#xD;
          -  pre- existing neurological deficit; neurologic limitation in daily life&#xD;
&#xD;
          -  emergency surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Grapow, Prof. Dr. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Herzchirurgie, Universitätsspital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herzchirurgie University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mitral valve surgery</keyword>
  <keyword>mitral valve stenosis</keyword>
  <keyword>mitral valve insufficiency</keyword>
  <keyword>minimal invasive mitral valve surgery</keyword>
  <keyword>neurological outcome</keyword>
  <!-- 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/NCT03798015
org study id: 2018-02143; ch18Grapow3
nct id: NCT03798015
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Reconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral
      thoracotomy technique in contrast to surgical approach by sternotomy. The minimal invasive
      approach is favourable regarding surgical trauma, length of hospital stay and amount of blood
      loss.

      This study is to investigate the neurological outcome after minimal- invasive mitral valve
      surgery compared to open mitral valve surgery by sternotomy.

      Pre-, intra- and postsurgical data from mitral valve surgery derived from the Basel mitral
      valve registry (collected from 2009 until now) will be analyzed.
observational model: Cohort
time perspective: Retrospective
measure: occurence of stroke (yes/ no) subsequent to mitral valve surgery
time frame: post surgical from day of surgery until day of discharge from hospital (approx. 2 weeks)
description: assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery
arm group label: mitral valve surgery
description: outcome of mitral valve surgery (stroke yes or no)
intervention type: Other
intervention name: mitral valve surgery
description: assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery
arm group label: mitral valve surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Martin Grapow, Prof. Dr. MD
role: Principal Investigator
affiliation: Klinik für Herzchirurgie, Universitätsspital Basel
facility: 
country: Switzerland
responsible party type: Sponsor