<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/NCT04503122</url>
  </required_header>
  <id_info>
    <org_study_id>BARO-AF</org_study_id>
    <nct_id>NCT04503122</nct_id>
  </id_info>
  <brief_title>Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation</brief_title>
  <acronym>BARO-AF</acronym>
  <official_title>Baroreflex Sensitivity in Patients Undergoing Atrial Fibrillation Ablation: Association With Arrhythmia Recurrences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atrial fibrillation is the most common arrhythmia. The posterior surface of the left atrium&#xD;
      is covered by an extensive network belonging to the autonomic nervous system that can be&#xD;
      damaged during the ablation. The involvement of the autonomous nervous system in the genesis&#xD;
      and maintenance of atrial fibrillation remains poorly understood. Baroreflex sensitivity is a&#xD;
      non-invasive method assessing autonomous nervous system activity.&#xD;
&#xD;
      The rate of atrial fibrillation recurrence after ablation is currently high and a better&#xD;
      understanding of the mechanisms associated with recurrence is essential to improve selection&#xD;
      of the patients who will benefit the most from this procedure.&#xD;
&#xD;
      The aim of this study is to evaluate the association between the baroreflex sensitivity and&#xD;
      atrial fibrillation recurrences and to analyze the prognostic contribution of the baroreflex&#xD;
      measurement compared to other published criteria.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 12, 2021</start_date>
  <completion_date type="Anticipated">October 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean slope assessed before ablation in the recurrence and the non-recurrence groups</measure>
    <time_frame>Recurrence is assessed at one year of follow-up</time_frame>
    <description>To compare baroreflex sensitivity assessed by mean Slope 1 month before the ablation in the recurrence group at 1 year and in the no AF recurrence group at 1 year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between baroreflex sensitivity assessed before ablation and atrial fibrillation burden</measure>
    <time_frame>Burden is assessed at one year of follow-up</time_frame>
    <description>Association between baroreflex sensitivity evaluated by mean slope, LF gain and HF gain 1 month before AF ablation and AF burden after 1 year of follow-up;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baroreflex sensitivity fall between the groups with and without AF recurrence</measure>
    <time_frame>Recurrence is assessed at one year of follow-up</time_frame>
    <description>To compare the baroreflex sensitivity fall between before and day1 of ablation between the groups with and without AF recurrence at 1 year follow-up ;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of baroreflex sensitivity</measure>
    <time_frame>Before, day 1 and month 3 after the ablation</time_frame>
    <description>To describe the evolution of baroreflex sensitivity in the group with and in the group without recurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological and imaging parameters</measure>
    <time_frame>Burden is assessed at one year of follow-up</time_frame>
    <description>To look for an association between biological and imaging parameters and atrial fibrillation burden at 1 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>before and at one year after atrial fibrillation ablation</time_frame>
    <description>To compare quality of life before and at one year after atrial fibrillation ablation in patients with and without AF recurrence;</description>
  </secondary_outcome>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pulmonary vein isolation</intervention_name>
    <description>pulmonary vein isolation : cryoablation or radiofrequency</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with paroxysmal atrial fibrillation undergoing atrial fibrillation ablation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old,&#xD;
&#xD;
          -  Patients with paroxysmal atrial fibrillation, hospitalized for atrial fibrillation&#xD;
             ablation,&#xD;
&#xD;
          -  Assessable baroreflex sensitivity before ablation,&#xD;
&#xD;
          -  Free subject, without guardianship or curatorship or subordination,&#xD;
&#xD;
          -  Patients benefiting from a Social Security assurance,&#xD;
&#xD;
          -  Informed consent signed by the patient after clear and fair information about the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18,&#xD;
&#xD;
          -  History of atrial fibrillation ablation,&#xD;
&#xD;
          -  Inability to calculate the baroreflex sensitivity&#xD;
&#xD;
          -  Contraindication to the performance of a cardiac CT scan (allergy to iodine, severe&#xD;
             renal insufficiency with clearance &lt;30 ml/mn/m2),&#xD;
&#xD;
          -  Inability to have continuous ECG recording by subcutaneous Holter,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rodrigue Garcia</last_name>
    <phone>+33549453729</phone>
    <email>sec.rythmologie@chu-poitiers.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire BOULETI, Pr</last_name>
      <email>claire-bouleti@chu-poitiers.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 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>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04503122
org study id: BARO-AF
nct id: NCT04503122
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Atrial fibrillation is the most common arrhythmia. The posterior surface of the left atrium
      is covered by an extensive network belonging to the autonomic nervous system that can be
      damaged during the ablation. The involvement of the autonomous nervous system in the genesis
      and maintenance of atrial fibrillation remains poorly understood. Baroreflex sensitivity is a
      non-invasive method assessing autonomous nervous system activity.

      The rate of atrial fibrillation recurrence after ablation is currently high and a better
      understanding of the mechanisms associated with recurrence is essential to improve selection
      of the patients who will benefit the most from this procedure.

      The aim of this study is to evaluate the association between the baroreflex sensitivity and
      atrial fibrillation recurrences and to analyze the prognostic contribution of the baroreflex
      measurement compared to other published criteria.
observational model: Cohort
time perspective: Prospective
measure: Mean slope assessed before ablation in the recurrence and the non-recurrence groups
time frame: Recurrence is assessed at one year of follow-up
description: To compare baroreflex sensitivity assessed by mean Slope 1 month before the ablation in the recurrence group at 1 year and in the no AF recurrence group at 1 year.
measure: Association between baroreflex sensitivity assessed before ablation and atrial fibrillation burden
time frame: Burden is assessed at one year of follow-up
description: Association between baroreflex sensitivity evaluated by mean slope, LF gain and HF gain 1 month before AF ablation and AF burden after 1 year of follow-up;
measure: Baroreflex sensitivity fall between the groups with and without AF recurrence
time frame: Recurrence is assessed at one year of follow-up
description: To compare the baroreflex sensitivity fall between before and day1 of ablation between the groups with and without AF recurrence at 1 year follow-up ;
measure: Evolution of baroreflex sensitivity
time frame: Before, day 1 and month 3 after the ablation
description: To describe the evolution of baroreflex sensitivity in the group with and in the group without recurrence.
measure: Biological and imaging parameters
time frame: Burden is assessed at one year of follow-up
description: To look for an association between biological and imaging parameters and atrial fibrillation burden at 1 year.
measure: Quality of life
time frame: before and at one year after atrial fibrillation ablation
description: To compare quality of life before and at one year after atrial fibrillation ablation in patients with and without AF recurrence;
intervention type: Procedure
intervention name: pulmonary vein isolation
description: pulmonary vein isolation : cryoablation or radiofrequency
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Rodrigue Garcia
phone: +33549453729
email: sec.rythmologie@chu-poitiers.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: Undecided