<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/NCT04460209</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-CIP-10316</org_study_id>
    <nct_id>NCT04460209</nct_id>
  </id_info>
  <brief_title>EP Device Registry</brief_title>
  <official_title>EP Device Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</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>
      This study will provide ongoing, high quality data on the safety, performance, and clinical&#xD;
      benefits of Abbott's EP devices in a real-world setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Anticipated">December 2031</completion_date>
  <primary_completion_date type="Anticipated">November 2030</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>The proportion of patients with a device- and/or procedure-related Serious Adverse Event</measure>
    <time_frame>7-days</time_frame>
    <description>that occurred within 7-days of the procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of procedures that achieved acute success.</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">7500</enrollment>
  <condition>Cardiac Rhythm Disorder</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of care mapping and/or ablation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female subjects of all ages who underwent an electrophysiology (EP) imaging&#xD;
        (diagnostic procedure) and/or ablation procedure that used at least one Abbott device&#xD;
        covered by this Registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject underwent an electrophysiology imaging (diagnostic procedure) and/or ablation&#xD;
             procedure that used one or more Abbott devices covered by this Registry.&#xD;
&#xD;
          -  Subject is willing and able to comply with the site's standard of care follow-up&#xD;
             schedule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is currently participating in another clinical investigation that may confound&#xD;
             the results of this Registry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Kristin Ruffner, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maxime De Groof, MMD</last_name>
    <phone>+32474567367</phone>
    <email>maxime.degroof@abbott.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>LaDina Ward, MPH</last_name>
    <phone>+17192482041</phone>
    <email>ladina.ward@abbott.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>KH Wiener Neustadt</name>
      <address>
        <city>Wiener Neustadt</city>
        <state>Lower Austria</state>
        <zip>2700</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina Mayr</last_name>
      <email>christina.mayr@wienerneustadt.lknoe.at</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>A. ö. Krankenhaus der Elisabethinen Linz</name>
      <address>
        <city>Linz</city>
        <state>Upr Aus</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carina Gutenbrunner</last_name>
      <email>Carina.Gutenbrunner@ordensklinikum.at</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>FN U sv. Anny v Brno</name>
      <address>
        <city>Brno</city>
        <state>Moravia-Silesia</state>
        <zip>65691</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alice Vybiralova</last_name>
      <email>alice.vybiralova@fnusa.cz</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pole Sante Republique</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Auvergne</state>
        <zip>92514</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas Caillot</last_name>
      <email>ncaillot@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Polyclinique des Fleurs</name>
      <address>
        <city>Ollioules</city>
        <state>Provence-Alpes-Azur</state>
        <zip>83190</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francine Moll</last_name>
      <email>moll@elsan.care</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Rhône-Durance</name>
      <address>
        <city>Avignon</city>
        <state>Provence-Alpes-Côte d'Azur</state>
        <zip>84082</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Deutsches Herzzentrum München des Freistaates Bayern</name>
      <address>
        <city>München</city>
        <state>Bavaria</state>
        <zip>80636</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sabine Brandhorst</last_name>
      <email>brandhorst@dhm.mhn.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medizinische Einrichtungen der Universität zu Köln</name>
      <address>
        <city>Köln</city>
        <state>North Rhine-Westphalia</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hans Guenther Balk</last_name>
      <email>hans-guenther.balk@uk-koeln.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Dresden GmbH Universitätsklinik</name>
      <address>
        <city>Dresde</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anastasia Hankel</last_name>
      <email>anastasia.hankel@herzzentrum-dresden.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Semmelweis University</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tamas Bodis</last_name>
      <email>studycenter.sekk21@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Christian Medical College &amp; Hospital</name>
      <address>
        <city>Vellore</city>
        <state>Tmlnadu</state>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rintu James</last_name>
      <email>rintujames96@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Max Super Specialty Hospital</name>
      <address>
        <city>New Delhi</city>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chandini Nair</last_name>
      <email>Chandini.C.Nair@maxhealthcare.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sree Chitra Tirunal Institute for Medical Sciences &amp; tech.</name>
      <address>
        <city>Trivandrum</city>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vineeth Cp</last_name>
      <email>vineethcp2868@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <state>Lombard</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caterina Bisceglia</last_name>
      <email>bisceglia.caterina@hsr.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario A. Gemelli</name>
      <address>
        <city>Roma</city>
        <state>Rome</state>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gaetano Pinnacchio</last_name>
      <email>gaetano.pinnacchio@hotmail.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale dell'Angelo</name>
      <address>
        <city>Mestre</city>
        <state>Veneto</state>
        <zip>30174</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paolo China, MD</last_name>
      <email>paolo.china@aulss3.veneto.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Pisana</name>
      <address>
        <city>Pisa</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raffaele De Lucia</last_name>
      <email>r.delucia.md@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <state>Friesland</state>
        <zip>8934AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dirk Jan De Boer</last_name>
      <email>dirkjan.de.boer@mcl.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <state>Utrecht - Canada</state>
        <zip>3435CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Haga Ziekenhuis Locatie Leyenburg</name>
      <address>
        <city>Den Haag</city>
        <state>Zuid-Holland</state>
        <zip>2545AA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadine De Roode</last_name>
      <email>n.deroode@hagaziekenhuis.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Santa Cruz</name>
      <address>
        <city>Carnaxide</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natacha Almeida</last_name>
      <email>natachaccca@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Marta</name>
      <address>
        <city>Lisboa</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mafalda Selas</last_name>
      <email>mafalda.selas@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de São João</name>
      <address>
        <city>Porto</city>
        <zip>4202-451</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liliana Meneses, Tech</last_name>
      <email>meneses.liliana87@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital General Juan Ramon Jimenez</name>
      <address>
        <city>Huelva</city>
        <state>Andalusia</state>
        <zip>21005</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Teresa Moraleda</last_name>
      <email>teresamoraleda@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <state>Catalon</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina Poza</last_name>
      <email>poza@clinic.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarre</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alicia Gainza Calleja, BN</last_name>
      <phone>+34848423320</phone>
      <email>alicia.gainza.calleja@navarra.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 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>Arrhythmias, Cardiac</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/NCT04460209
org study id: ABT-CIP-10316
nct id: NCT04460209
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will provide ongoing, high quality data on the safety, performance, and clinical
      benefits of Abbott's EP devices in a real-world setting.
observational model: Cohort
time perspective: Prospective
measure: The proportion of patients with a device- and/or procedure-related Serious Adverse Event
time frame: 7-days
description: that occurred within 7-days of the procedure.
measure: The proportion of procedures that achieved acute success.
time frame: Baseline
intervention type: Other
intervention name: Standard of Care
description: Standard of care mapping and/or ablation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Kristin Ruffner, PhD
role: Study Director
affiliation: Abbott
last name: Maxime De Groof, MMD
phone: +32474567367
email: maxime.degroof@abbott.com
last name: LaDina Ward, MPH
phone: +17192482041
email: ladina.ward@abbott.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Austria
country: Czechia
country: France
country: Germany
country: Hungary
country: India
country: Italy
country: Netherlands
country: Portugal
country: Spain
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
sharing ipd: No