<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/NCT03768180</url>
  </required_header>
  <id_info>
    <org_study_id>IETAVR</org_study_id>
    <nct_id>NCT03768180</nct_id>
  </id_info>
  <brief_title>Infective Endocarditis After TAVR</brief_title>
  <acronym>INTENSE</acronym>
  <official_title>INfecTive ENdocarditis After Transcatheter Aortic Valve Replacement (TAVR) a National SwEdish Study (INTENSE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims at studying the frequency of infective endocarditis after transcatheter&#xD;
      aortic valve replacement/implantation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the start of transcatheter aortic valve implnatations/replacements (TAVR/TAVI)&#xD;
      implantations in Sweden in 2008 all procedures have been added to a national database, which&#xD;
      now contains 4500+ procedures. At the same time, all admissions to the hospital is also&#xD;
      recorded with diagnosis in a separate database. We intend to make a nation-wide complete&#xD;
      follow up of all TAVR/TAVI patients in swede that has received the diagnosis of infective&#xD;
      endocarditis after the implantation. In addition data will also be collected from the&#xD;
      national endocarditis database for detailed information of the cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</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>Infective Endocarditis</measure>
    <time_frame>5 year</time_frame>
    <description>Patients that have suffered an infective endocarditis will be described, where survival is one important variable</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4600</enrollment>
  <condition>Infective Endocarditis of Aortic Valve</condition>
  <arm_group>
    <arm_group_label>Patient with infective endocarditis</arm_group_label>
    <description>All patients diagnosed with infective endocarditis after TAVR</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients that has under TAVR/TAVI in Sweden between 2008 and 2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients that has under TAVR/TAVI in Sweden between 2008 and 2018&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients unable to follow up due to emigration or missing social security number&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Skane University Hospital</name>
      <address>
        <city>Lund</city>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>April 3, 2020</last_update_submitted>
  <last_update_submitted_qc>April 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 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>Endocarditis, Bacterial</mesh_term>
    <mesh_term>Endocarditis</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/NCT03768180
org study id: IETAVR
nct id: NCT03768180
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aims at studying the frequency of infective endocarditis after transcatheter
      aortic valve replacement/implantation
Since the start of transcatheter aortic valve implnatations/replacements (TAVR/TAVI)
      implantations in Sweden in 2008 all procedures have been added to a national database, which
      now contains 4500+ procedures. At the same time, all admissions to the hospital is also
      recorded with diagnosis in a separate database. We intend to make a nation-wide complete
      follow up of all TAVR/TAVI patients in swede that has received the diagnosis of infective
      endocarditis after the implantation. In addition data will also be collected from the
      national endocarditis database for detailed information of the cases.
observational model: Cohort
time perspective: Retrospective
measure: Infective Endocarditis
time frame: 5 year
description: Patients that have suffered an infective endocarditis will be described, where survival is one important variable
arm group label: Patient with infective endocarditis
description: All patients diagnosed with infective endocarditis after TAVR
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Endocarditis, Bacterial
mesh term: Endocarditis
sharing ipd: No