<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/NCT03774550</url>
  </required_header>
  <id_info>
    <org_study_id>2018-05Obs-CHRMT</org_study_id>
    <nct_id>NCT03774550</nct_id>
  </id_info>
  <brief_title>Atrial Fibrillation Ablation: Radiofrequency or Cryoablation?</brief_title>
  <acronym>ARCFA</acronym>
  <official_title>A Comparison of Radiofrequency Catheter Ablation With or Without Contact-force and Cryoablation for Paroxysmal Atrial Fibrillation Ablation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional Metz-Thionville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Régional Metz-Thionville</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 study aims to compare 3 techniques routinely used for paroxysmal atrial fibrillation&#xD;
      ablation: radiofrequency catheter ablation without contact-force, radiofrequency catheter&#xD;
      ablation with contact-force and cryoablation. The hypothesis is the non-inferiority between&#xD;
      the 3 techniques in terms of free-from atrial fibrillation survival (primary criteria). It&#xD;
      will also compare lenght of procedure, radioscopy time and immediate complications (secondary&#xD;
      criteria).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 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>Atrial Fibrillation survival</measure>
    <time_frame>Day 1</time_frame>
    <description>Free from atrial fibrillation survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immediate complications</measure>
    <time_frame>Day 1</time_frame>
    <description>The number of immediate complications encountered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radioscopy duration</measure>
    <time_frame>Day 1</time_frame>
    <description>Radioscopy duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lenght of procedure</measure>
    <time_frame>Day 1</time_frame>
    <description>Overall duration of the procedure</description>
  </secondary_outcome>
  <enrollment type="Actual">206</enrollment>
  <condition>Atrial Fibrillation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had an atrial fibrillation for symptomatic paroxysmal atrial fibrillation,&#xD;
        refractory to antiarrhythmic drugs, between 01/01/2014 and 30/09/2017 in CHR&#xD;
        Metz-Thionville&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who had an atrial fibrillation for symptomatic paroxysmal atrial&#xD;
             fibrillation, refractory to antiarrhythmic drugs, between 01/01/2014 and 30/09/2017 in&#xD;
             CHR Metz-Thionville&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not willing to participate via using their medical files&#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>CHR Metz Thionville</name>
      <address>
        <city>Metz</city>
        <state>Moselle</state>
        <zip>57085</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>May 13, 2019</last_update_submitted>
  <last_update_submitted_qc>May 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Catheter ablation</keyword>
  <keyword>Radiofrequency</keyword>
  <keyword>Contact-force</keyword>
  <keyword>Cryoablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT03774550
org study id: 2018-05Obs-CHRMT
nct id: NCT03774550
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to compare 3 techniques routinely used for paroxysmal atrial fibrillation
      ablation: radiofrequency catheter ablation without contact-force, radiofrequency catheter
      ablation with contact-force and cryoablation. The hypothesis is the non-inferiority between
      the 3 techniques in terms of free-from atrial fibrillation survival (primary criteria). It
      will also compare lenght of procedure, radioscopy time and immediate complications (secondary
      criteria).
observational model: Cohort
time perspective: Retrospective
measure: Atrial Fibrillation survival
time frame: Day 1
description: Free from atrial fibrillation survival
measure: Immediate complications
time frame: Day 1
description: The number of immediate complications encountered
measure: Radioscopy duration
time frame: Day 1
description: Radioscopy duration
measure: Lenght of procedure
time frame: Day 1
description: Overall duration of the procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Atrial Fibrillation