<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/NCT04501835</url>
  </required_header>
  <id_info>
    <org_study_id>2020PI077</org_study_id>
    <nct_id>NCT04501835</nct_id>
  </id_info>
  <brief_title>Assessment of Diagnostic and Therapeutic Practices for Cardiac Implantable Electronic Devices Suspected Infections in Nancy University Hospital</brief_title>
  <official_title>Assessment of Diagnostic and Therapeutic Practices for Cardiac Implantable Electronic Devices Suspected Infections in Nancy University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      The frequency of cardiac implantable electronic devices (CIED) is constantly increasing.&#xD;
&#xD;
      Devices infections are one of the most serious complications in terms of morbidity and&#xD;
      mortality. Although the frequency of cardiac implantable devices infections is difficult to&#xD;
      derminate due to divergent definitions, cohort studies report a trend of increasing.&#xD;
&#xD;
      The infection can be localized at the pocket of the implantation, at intravascular or&#xD;
      intra-cardiac portion of leads. Infectious endocarditis defined by involvement of the&#xD;
      intra-cardiac portion of leads is the most serious form. The diagnosis is based on clinical,&#xD;
      biological and multimodal imagery data. Early diagnosis and specific management are necessary&#xD;
      to reduce mortality and morbidity.&#xD;
&#xD;
      Since the last European recommendations on infectious endocarditis in 2015, the HeartRythm&#xD;
      Society of patient described an algorithm to treat CIED infections and extraction&#xD;
      indications.&#xD;
&#xD;
      However, in practice, management of CEID infections remains center-dependent and data from&#xD;
      robust international studies are missing.&#xD;
&#xD;
      The main objective of our study is to evaluate the management of CEID suspected infections&#xD;
      and the prognosis at 1 year in terms of survival according to the methods of treatment at the&#xD;
      Nancy University Hospital and to compare the treatment with the latest recommendations in&#xD;
      force&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2019</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Description of the practice</measure>
    <time_frame>From January 2014 to July 2020</time_frame>
    <description>Describe the diagnostic and therapeutic practices of patients hospitalized for CIED suspected infection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of local practices against current recommendations</measure>
    <time_frame>From January 2014 to July 2020</time_frame>
    <description>Classify patients in 3 groups (1 = Cardiac implantable electronic device infection ; 2 Pocket infection without proof of lead involvements ; 3 = systemic infection related to infective valvular endocarditis or not without proof of lead involvements according to our local practices and criteria, to EHRA criteria and modified Duke Li criteria).&#xD;
Compare diagnostic management in our center with EHRA recommendations in each groups&#xD;
Compare therapeutic management including removal/extraction of cardiac implantable electronic device, antibiotic therapy&#xD;
Assessment of adhering to EHRA recommendations&#xD;
Pronostic evaluation according to removal/extraction or not based on survival curve</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">184</enrollment>
  <condition>Cardiac Implantable Electronic Device Infections</condition>
  <arm_group>
    <arm_group_label>Cardiac implantable electronic device infections</arm_group_label>
    <description>Patients hospitalised in Nancy University Hospital for suspected cardiac implantable electronic device infections</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diagnostic and treatment evaluation</intervention_name>
    <description>No intervention, description of the diagnostic evaluation and the treatment</description>
    <arm_group_label>Cardiac implantable electronic device infections</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized in Nancy University Hospital between January 2014 et July 2019 for&#xD;
        CIED suspected infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who have been hospitalized in Nancy University Hospital between January&#xD;
             2014 et July 2019 for suspected infection of cardiac implantable electronic device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patients&#xD;
&#xD;
          -  Epicardial CIED&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>De Ciancio</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. doi: 10.1016/j.jacc.2011.04.033.</citation>
    <PMID>21867833</PMID>
  </reference>
  <reference>
    <citation>Joy PS, Kumar G, Poole JE, London B, Olshansky B. Cardiac implantable electronic device infections: Who is at greatest risk? Heart Rhythm. 2017 Jun;14(6):839-845. doi: 10.1016/j.hrthm.2017.03.019. Epub 2017 Mar 16.</citation>
    <PMID>28315744</PMID>
  </reference>
  <reference>
    <citation>Habib G, Lancellotti P, Antunes MJ, Bongiorni MG, Casalta JP, Del Zotti F, Dulgheru R, El Khoury G, Erba PA, Iung B, Miro JM, Mulder BJ, Plonska-Gosciniak E, Price S, Roos-Hesselink J, Snygg-Martin U, Thuny F, Tornos Mas P, Vilacosta I, Zamorano JL; ESC Scientific Document Group. 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015 Nov 21;36(44):3075-3128. doi: 10.1093/eurheartj/ehv319. Epub 2015 Aug 29. No abstract available.</citation>
    <PMID>26320109</PMID>
  </reference>
  <reference>
    <citation>Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available. Erratum In: Heart Rhythm. 2021 Oct;18(10):1814.</citation>
    <PMID>28919379</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymous individual datas for baseline characteristcs and clinical outcomes would be available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>1 year</ipd_time_frame>
    <ipd_access_criteria>Data access request will be reviewed by investigator team. Requestors will be required to signe a data access agreement</ipd_access_criteria>
  </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/NCT04501835
org study id: 2020PI077
nct id: NCT04501835
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The frequency of cardiac implantable electronic devices (CIED) is constantly increasing.

      Devices infections are one of the most serious complications in terms of morbidity and
      mortality. Although the frequency of cardiac implantable devices infections is difficult to
      derminate due to divergent definitions, cohort studies report a trend of increasing.

      The infection can be localized at the pocket of the implantation, at intravascular or
      intra-cardiac portion of leads. Infectious endocarditis defined by involvement of the
      intra-cardiac portion of leads is the most serious form. The diagnosis is based on clinical,
      biological and multimodal imagery data. Early diagnosis and specific management are necessary
      to reduce mortality and morbidity.

      Since the last European recommendations on infectious endocarditis in 2015, the HeartRythm
      Society of patient described an algorithm to treat CIED infections and extraction
      indications.

      However, in practice, management of CEID infections remains center-dependent and data from
      robust international studies are missing.

      The main objective of our study is to evaluate the management of CEID suspected infections
      and the prognosis at 1 year in terms of survival according to the methods of treatment at the
      Nancy University Hospital and to compare the treatment with the latest recommendations in
      force
observational model: Case-Only
time perspective: Retrospective
measure: Description of the practice
time frame: From January 2014 to July 2020
description: Describe the diagnostic and therapeutic practices of patients hospitalized for CIED suspected infection
measure: Evaluation of local practices against current recommendations
time frame: From January 2014 to July 2020
description: Classify patients in 3 groups (1 = Cardiac implantable electronic device infection ; 2 Pocket infection without proof of lead involvements ; 3 = systemic infection related to infective valvular endocarditis or not without proof of lead involvements according to our local practices and criteria, to EHRA criteria and modified Duke Li criteria).
Compare diagnostic management in our center with EHRA recommendations in each groups
Compare therapeutic management including removal/extraction of cardiac implantable electronic device, antibiotic therapy
Assessment of adhering to EHRA recommendations
Pronostic evaluation according to removal/extraction or not based on survival curve
arm group label: Cardiac implantable electronic device infections
description: Patients hospitalised in Nancy University Hospital for suspected cardiac implantable electronic device infections
intervention type: Other
intervention name: Diagnostic and treatment evaluation
description: No intervention, description of the diagnostic evaluation and the treatment
arm group label: Cardiac implantable electronic device infections
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. doi: 10.1016/j.jacc.2011.04.033.
PMID: 21867833
citation: Joy PS, Kumar G, Poole JE, London B, Olshansky B. Cardiac implantable electronic device infections: Who is at greatest risk? Heart Rhythm. 2017 Jun;14(6):839-845. doi: 10.1016/j.hrthm.2017.03.019. Epub 2017 Mar 16.
PMID: 28315744
citation: Habib G, Lancellotti P, Antunes MJ, Bongiorni MG, Casalta JP, Del Zotti F, Dulgheru R, El Khoury G, Erba PA, Iung B, Miro JM, Mulder BJ, Plonska-Gosciniak E, Price S, Roos-Hesselink J, Snygg-Martin U, Thuny F, Tornos Mas P, Vilacosta I, Zamorano JL; ESC Scientific Document Group. 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015 Nov 21;36(44):3075-3128. doi: 10.1093/eurheartj/ehv319. Epub 2015 Aug 29. No abstract available.
PMID: 26320109
citation: Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available. Erratum In: Heart Rhythm. 2021 Oct;18(10):1814.
PMID: 28919379
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
sharing ipd: Yes
ipd description: Anonymous individual datas for baseline characteristcs and clinical outcomes would be available
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 1 year
ipd access criteria: Data access request will be reviewed by investigator team. Requestors will be required to signe a data access agreement