<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/NCT04496336</url>
  </required_header>
  <id_info>
    <org_study_id>NOISE-AF</org_study_id>
    <nct_id>NCT04496336</nct_id>
  </id_info>
  <brief_title>Non-invasive Substrate Evaluation in Atrial Fibrillation</brief_title>
  <acronym>NOISE-AF</acronym>
  <official_title>Non-invasive Substrate Evaluation in Atrial Fibrillation Using Cardiac Magnetic Resonance and Electrocardiographic Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gregorio Marañón Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Clinic of Barcelona</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>
      The study aims to assess the right and left atrial electrophysiological substrate in atrial&#xD;
      fibrillation patients using the invasive electroanatomic map (basal and with extraestimulus)&#xD;
      as well as its correlation with cardiac magnetic resonance and electrocardiographic imaging.&#xD;
      The results will also be compared when the patient is in sinus rhythm and atrial&#xD;
      fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2020</start_date>
  <completion_date type="Actual">November 20, 2022</completion_date>
  <primary_completion_date type="Actual">October 20, 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>Correlation between conduction velocity and MRI fibrosis.</measure>
    <time_frame>Baseline</time_frame>
    <description>The conduction velocity in sinusal rhythm and with extra estimuli will be correlated with the MRI late gadolinium enhancement sequence (MRI-LGE).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between voltage and MRI fibrosis.</measure>
    <time_frame>Baseline</time_frame>
    <description>The voltage in sinus rhythm and in atrial fibrillation will be correlated with the MRI-LGE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between electrocardiographic image (ECGi) and MRI-LGE.</measure>
    <time_frame>Baseline</time_frame>
    <description>The xxx of the ECGi will be correlated with the MRI-LGE.</description>
  </secondary_outcome>
  <enrollment type="Actual">52</enrollment>
  <condition>C14.280.067.198</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with persistent or paroxysmal atrial fibrillation, without cardiomyopathy (LVEF&gt;&#xD;
        40%) or significant valvulopathy who will undergo first AF ablation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Atrial fibrillation paroxysmal or persistent with criteria for percutaneous ablation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiomiopathy (FEVI&lt;40%) or significant valvulopathy.&#xD;
&#xD;
          -  MRI not possible or contraindicated.&#xD;
&#xD;
          -  Previous atrial fibrillation ablation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Josep Lluis Mont Girbau</investigator_full_name>
    <investigator_title>Head of Arrythmia Unit</investigator_title>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Paroxysmal Atrial Fibrillation</keyword>
  <keyword>Persistent Atrial Fibrillation</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/NCT04496336
org study id: NOISE-AF
nct id: NCT04496336
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The study aims to assess the right and left atrial electrophysiological substrate in atrial
      fibrillation patients using the invasive electroanatomic map (basal and with extraestimulus)
      as well as its correlation with cardiac magnetic resonance and electrocardiographic imaging.
      The results will also be compared when the patient is in sinus rhythm and atrial
      fibrillation.
observational model: Cohort
time perspective: Prospective
measure: Correlation between conduction velocity and MRI fibrosis.
time frame: Baseline
description: The conduction velocity in sinusal rhythm and with extra estimuli will be correlated with the MRI late gadolinium enhancement sequence (MRI-LGE).
measure: Correlation between voltage and MRI fibrosis.
time frame: Baseline
description: The voltage in sinus rhythm and in atrial fibrillation will be correlated with the MRI-LGE.
measure: Correlation between electrocardiographic image (ECGi) and MRI-LGE.
time frame: Baseline
description: The xxx of the ECGi will be correlated with the MRI-LGE.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Josep Lluis Mont Girbau
investigator title: Head of Arrythmia Unit
mesh term: Atrial Fibrillation