xml: <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/NCT05961865</url>
    </required_header>
    <id_info>
      <org_study_id>6672</org_study_id>
      <nct_id>NCT05961865</nct_id>
    </id_info>
    <brief_title>Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation</brief_title>
    <acronym>POLICARDIOFA</acronym>
    <official_title>Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Milan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</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>
        It is a non-pharmacological (biological), spontaneous observational study. The main objective&#xD;
        is to evaluate the correlation between inflammation markers and local adiposity, clinical&#xD;
        risk factors and their possible variation following an AF ablation procedure&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study includes the execution of a sample for each time point for the evaluation of&#xD;
        inflammation and fibrosis markers identified so far in the literature, such as Interleukin 6,&#xD;
        N-terminal propeptide of procollagen type 1 (P1NP), chitinase-3-like protein 1 (YKL-40),&#xD;
        tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and&#xD;
        omega-3 fatty acids.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 11, 2023</start_date>
    <completion_date type="Anticipated">August 2027</completion_date>
    <primary_completion_date type="Anticipated">July 2027</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>Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment.</measure>
      <time_frame>One year</time_frame>
      <description>Outcome measured through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate.</measure>
      <time_frame>One year</time_frame>
      <description>Identify how many AF patients undergoing ablation have a reduction in related symptoms such as shortness of breath, feeling tired and weakness. The patient will answer an EQ-5D-5L questionnaire for symptom assessment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping.</measure>
      <time_frame>One year</time_frame>
      <description>Relationship between the degree of inflammation and atrial fibrosis detected through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol) and the degree of atrial fibrosis detected on mapping electroanatomical (voltage map)</description>
    </secondary_outcome>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Atrial Fibrillation</condition>
    <condition>Marker of Inflammation</condition>
    <condition>Inflammation</condition>
    <condition>Arrhythmia</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Markers of inflammation and fibrosis</intervention_name>
      <description>Will be analyzed the following inflammation markers:&#xD;
  Interleukin 6, N-terminal propeptide of type 1 procollagen (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.</description>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood aliquot will be analyzed for the evaluation of markers of atrial inflammation and&#xD;
        fibrosis identified so far in the literature, such as Interleukin 6, N-terminal propeptide of&#xD;
        procollagen type 1 (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor&#xD;
        (TNF-alpha) , GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with Paroxysmal or Persistent Atrial Fibrillation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Paroxysmal or persistent AF;&#xD;
  &#xD;
            -  Patients undergoing ESC/ERAH(European Society of Cardiology/European Heart Rhythm&#xD;
               Association) approved catheter ablation procedures;&#xD;
  &#xD;
            -  Aged between 18 and 85 years;&#xD;
  &#xD;
            -  Ability to provide informed consent for study participation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 85 years or &lt; 18 years;&#xD;
  &#xD;
            -  Presence of left auricular thrombosis on pre-procedural transesophageal&#xD;
               echocardiogram;&#xD;
  &#xD;
            -  NYHA functional class IV;&#xD;
  &#xD;
            -  Left ventricular ejection fraction &lt;30%;&#xD;
  &#xD;
            -  Myocardial infarction or unstable angina or recent coronary artery bypass graft (&lt;6&#xD;
               months);&#xD;
  &#xD;
            -  Significant co-morbidity, such as cancer, severe renal failure requiring dialysis,&#xD;
               severe obstructive pulmonary disease, cirrhosis, with a life expectancy of less than&#xD;
               12 months;&#xD;
  &#xD;
            -  Presence of contraindications to the procedure;&#xD;
  &#xD;
            -  Inability to provide informed consent for study participation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stefano Carugo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stefano Carugo, MD</last_name>
      <phone>+390255033532</phone>
      <email>stefano.carugo@policlinico.mi.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</name>
        <address>
          <city>Milan</city>
          <zip>20122</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stefano Carugo, MD</last_name>
        <phone>+39 0255033579</phone>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 9, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</investigator_affiliation>
      <investigator_full_name>Stefano Carugo</investigator_full_name>
      <investigator_title>Director of the Department of Cardio-Thoracic-Vascular Diseases</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05961865
  org study id: 6672
  nct id: NCT05961865
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  It is a non-pharmacological (biological), spontaneous observational study. The main objective
        is to evaluate the correlation between inflammation markers and local adiposity, clinical
        risk factors and their possible variation following an AF ablation procedure
  The study includes the execution of a sample for each time point for the evaluation of
        inflammation and fibrosis markers identified so far in the literature, such as Interleukin 6,
        N-terminal propeptide of procollagen type 1 (P1NP), chitinase-3-like protein 1 (YKL-40),
        tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and
        omega-3 fatty acids.
  observational model: Cohort
  time perspective: Prospective
  measure: Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment.
  time frame: One year
  description: Outcome measured through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol).
  measure: Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate.
  time frame: One year
  description: Identify how many AF patients undergoing ablation have a reduction in related symptoms such as shortness of breath, feeling tired and weakness. The patient will answer an EQ-5D-5L questionnaire for symptom assessment
  measure: Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping.
  time frame: One year
  description: Relationship between the degree of inflammation and atrial fibrosis detected through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol) and the degree of atrial fibrosis detected on mapping electroanatomical (voltage map)
  intervention type: Diagnostic Test
  intervention name: Markers of inflammation and fibrosis
  description: Will be analyzed the following inflammation markers:
  Interleukin 6, N-terminal propeptide of type 1 procollagen (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.
  Blood aliquot will be analyzed for the evaluation of markers of atrial inflammation and
        fibrosis identified so far in the literature, such as Interleukin 6, N-terminal propeptide of
        procollagen type 1 (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor
        (TNF-alpha) , GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Stefano Carugo, MD
  role: Principal Investigator
  affiliation: IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
  last name: Stefano Carugo, MD
  phone: +390255033532
  email: stefano.carugo@policlinico.mi.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  investigator full name: Stefano Carugo
  investigator title: Director of the Department of Cardio-Thoracic-Vascular Diseases
  mesh term: Atrial Fibrillation
  mesh term: Inflammation
  sharing ipd: No