<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/NCT03757741</url>
  </required_header>
  <id_info>
    <org_study_id>CM0318-FIR</org_study_id>
    <nct_id>NCT03757741</nct_id>
  </id_info>
  <brief_title>Inflammation, Fibrosis and Risk of Recurrence After Atrial Fibrillation Ablation</brief_title>
  <acronym>FIBRO-RISK</acronym>
  <official_title>Impact of Inflammation-mediated Myocardial Fibrosis on the Risk of Recurrence After Successful Ablation of Atrial Fibrillation - the FIBRO-RISK Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardio Med Medical Center</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Targu Mures, Romania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital of Targu Mures, Romania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardio Med Medical Center</source>
  <brief_summary>
    <textblock>
      FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis&#xD;
      on the risk of recurrence after successful ablation of atrial fibrillation. The level of&#xD;
      systemic inflammation in the pre-ablation and immediate post-ablation period will be assessed&#xD;
      on the basis of serum levels of inflammatory biomarkers (hs-CRP, matrix metalloproteases,&#xD;
      interleukin-6), while the level of cardiac fibrosis will be determined based on MRI imaging&#xD;
      associated with complex post-processing techniques for mapping myocardial fibrosis at the&#xD;
      level of left atrium and left ventricle. At the same time, the amount of epicardial fat will&#xD;
      serve as an indirect marker of localized inflammation and will be determined at different&#xD;
      levels in the heart (surrounding left atrium, right atrium or the entire heart), while&#xD;
      ventricular function will be assessed on the basis of serum levels of NT pro-BNP prior to the&#xD;
      procedure. All these parameters will be investigated in patients with successful ablation of&#xD;
      AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at&#xD;
      1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the&#xD;
      following biomarkers will be determined: serum levels of inflammatory biomarkers and&#xD;
      NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the&#xD;
      level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial&#xD;
      fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.&#xD;
&#xD;
      The primary endpoint of the study will be represented by the rate of AF recurrence at 1-year&#xD;
      post ablation, documented by either ECG or Holter monitoring.&#xD;
&#xD;
      The secondary endpoints of the study will be:&#xD;
&#xD;
        -  rate of re-hospitalization&#xD;
&#xD;
        -  rate of survival without relapse&#xD;
&#xD;
        -  rate of major adverse cardiovascular events (MACE rate, including cardiovascular death&#xD;
           or stroke)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of atrial fibrillation (AF) is on the rise, being the most frequent sustained&#xD;
      supraventricular arrhythmia and a health issue by its increased morbidity and mortality. In&#xD;
      most of the cases, myocardial tissue located at the level of the pulmonary veins represents&#xD;
      the trigger for atrial fibrillation. The pathophysiology of AF is still incompletely&#xD;
      understood, several studies suggesting that profibrotic and inflammatory processes have a&#xD;
      crucial role in the development of AF. So far the success rate of AF ablation is not very&#xD;
      high, reaching 70% in patients with paroxysmal AF and 50% in cases with persistent AF.&#xD;
      Several risk factors for the occurrence and recurrence of AF have been described in the&#xD;
      literature, including left atrial enlargement, left ventricular dysfunction, epicardial fat&#xD;
      volume, and myocardial fibrosis caused by local atrial inflammation. What remains to be&#xD;
      investigated is the relationship between these risk factors and the recurrence of AF after&#xD;
      radiofrequency catheter ablation using advanced 3D mapping system.&#xD;
&#xD;
      This is a clinical prospective, descriptive, single-center study which will be carried out in&#xD;
      the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed Tirgu Mures, Romania.&#xD;
      The duration of the study is 2 years which include the initial screening and the follow-up&#xD;
      period for the recurrence of AF.&#xD;
&#xD;
      The study will include 100 subjects suitable for catheter ablation. Imaging biomarkers and&#xD;
      laboratory analyses such as high sensitive C Reactive Protein (hsCRP), matrix&#xD;
      metalloproteases (MMP), interleukin-6 (IL6) and N-Terminal Pro-B-Type Natriuretic Peptide (NT&#xD;
      pro-BNP) will be determined in the first 24 hours after the procedure. The anatomy of&#xD;
      pulmonary veins, atrial fibrosis, atrial volumes and the amount of epicardial fat will be&#xD;
      evaluated and quantified with late gadolinium-enhancement cardiac magnetic resonance&#xD;
      (LGE-CMR). All these parameters will be investigated in patients with successful ablation of&#xD;
      AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at&#xD;
      1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the&#xD;
      following biomarkers will be determined: serum levels of inflammatory biomarkers and&#xD;
      NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the&#xD;
      level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial&#xD;
      fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.&#xD;
&#xD;
      The study will be conducted over a period of 2 years, in which patients will be examined at&#xD;
      baseline, and will be followed-up for recurrence of AF.&#xD;
&#xD;
      All patients will sign an informed written consent and will be checked for the exclusion&#xD;
      criteria prior to enrolment.&#xD;
&#xD;
      Study objectives:&#xD;
&#xD;
      Primary: To investigate the correlation between imaging markers provided by cardiac magnetic&#xD;
      resonance (including the degree of left atrial and ventricular fibrosis, left and right&#xD;
      atrial volume, epicardial fat tissue volume), inflammatory biomarkers, and the risk of AF&#xD;
      recurrence post ablation.&#xD;
&#xD;
      Secondary: To investigate the correlation between structural remodeling of the left and right&#xD;
      atrium, epicardial fat tissue volume and serum inflammatory biomarkers in patients with AF.&#xD;
&#xD;
      Study Timeline:&#xD;
&#xD;
        -  Baseline (day 0)&#xD;
&#xD;
        -  Obtain and document consent from participant on study consent form.&#xD;
&#xD;
        -  Verify inclusion/exclusion criteria.&#xD;
&#xD;
        -  Obtain demographic information, medical history, medication history, alcohol, and&#xD;
           tobacco use history.&#xD;
&#xD;
        -  Record results of physical examinations and 12-lead ECG.&#xD;
&#xD;
        -  Collect blood specimens (complete blood count, biochemistry and inflammatory&#xD;
           biomarkers).&#xD;
&#xD;
        -  Imaging procedures: transthoracic 2-D echocardiography, late gadolinium-enhancement&#xD;
           cardiac magnetic resonance&#xD;
&#xD;
        -  Visit 1 (month 1,3,6,12)&#xD;
&#xD;
        -  Record results of physical examinations, 12-lead ECG and medical history.&#xD;
&#xD;
        -  Imaging procedures: transthoracic 2-D echocardiography&#xD;
&#xD;
        -  Final study visit (month 12)&#xD;
&#xD;
        -  Record results of physical examinations, medical history,12-lead ECG and determination&#xD;
           of serum levels of inflammatory biomarkers and NT-proBNP&#xD;
&#xD;
        -  Imaging procedures: transthoracic 2-D echocardiography&#xD;
&#xD;
        -  End-point evaluation.&#xD;
&#xD;
      Study procedures:&#xD;
&#xD;
        -  Medical history, clinical examination, laboratory tests (complete blood count,&#xD;
           biochemistry, serum level of hs-CRP, MMP, IL6, and NT-pro-BNP);&#xD;
&#xD;
        -  12-lead ECG&#xD;
&#xD;
        -  2D transthoracic echocardiography with measurement of cardiac diameters, volumes,&#xD;
           valvular function and regurgitation, pressure gradients, left ventricular systolic and&#xD;
           diastolic function and ejection fraction.&#xD;
&#xD;
        -  Late Gadolinium-Enhancement Cardiac Magnetic Resonance (LGE-CMR) with the evaluation of&#xD;
           left and right atrial volume, the volume of epicardial adipose tissue, the degree of&#xD;
           atrial and ventricular fibrosis&#xD;
&#xD;
        -  Pulmonary vein isolation radiofrequency ablation with advanced 3D mapping system&#xD;
&#xD;
      Data collection: All the information will be collected in a database that consists of&#xD;
      patient's background, medical history, medication, imaging features provided by cardiac&#xD;
      ultrasound, Cardiac magnetic resonance and CMR imaging post-processing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 1, 2021</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>The rate of AF recurrence after pulmonary vein isolation</measure>
    <time_frame>12 months</time_frame>
    <description>The primary outcome measure will be represented by the rate of AF recurrence at 1 year post ablation, documented by either ECG or Holter monitoring.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of re-hospitalization</measure>
    <time_frame>12 months</time_frame>
    <description>The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of survival without relapse</measure>
    <time_frame>12 months</time_frame>
    <description>The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)</measure>
    <time_frame>12 months</time_frame>
    <description>The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Atrial Inflammation</condition>
  <arm_group>
    <arm_group_label>AF-SG 01</arm_group_label>
    <description>Study subjects with atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AF-SG 02</arm_group_label>
    <description>Study subjects without atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cardiac imaging tests</intervention_name>
    <description>2D transthoracic echocardiography; Late gadolinium-enhancement cardiac magnetic resonance with the evaluation of pulmonary veins anatomy, atrial fibrosis, atrial volumes and the amount of epicardial fat will</description>
    <arm_group_label>AF-SG 01</arm_group_label>
    <arm_group_label>AF-SG 02</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Venous blood samle collection</intervention_name>
    <description>Venous blood sample collection 1 day prior to the ablation procedure: Serum levels of high sensitive C Reactive Protein, Matrix metalloproteases, Interleukin-6, and N-Terminal Pro-B-Type Natriuretic Peptide.</description>
    <arm_group_label>AF-SG 01</arm_group_label>
    <arm_group_label>AF-SG 02</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population includes patients from a single center with paroxysmal and persistent&#xD;
        atrial fibrillation, meeting inclusion and exclusion criteria and undergoing pulmonary vein&#xD;
        isolation radiofrequency catheter ablation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with non-valvular paroxysmal or persistent atrial fibrillation who undergo&#xD;
             successful ablation of atrial fibrillation, either by cryoablation or by&#xD;
             radiofrequency advanced 3D mapping system;&#xD;
&#xD;
          -  Ability to provide informed consent;&#xD;
&#xD;
          -  Patients aged at least 18 years;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with valvular atrial fibrillation;&#xD;
&#xD;
          -  Patients with acute coronary syndrome in the last 30 days&#xD;
&#xD;
          -  Patients in whom atrial fibrillation is presumed to be caused by hyperthyreosis&#xD;
&#xD;
          -  Patients with long-standing persistent or permanent atrial fibrillation;&#xD;
&#xD;
          -  Unwillingness or incapacity to provide informed consent;&#xD;
&#xD;
          -  Allergy to gadolinium contrast media;&#xD;
&#xD;
          -  Absolute or relative contraindications to magnetic resonance imaging&#xD;
&#xD;
          -  Pregnancy or lactation;&#xD;
&#xD;
          -  Women with childbearing potential in absence of any contraceptive treatment&#xD;
&#xD;
          -  Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring&#xD;
             dialysis;&#xD;
&#xD;
          -  Active malignancy or malignancy within the last 5 year prior to enrollment;&#xD;
&#xD;
          -  Conditions associated with an estimated life expectancy of under 2 years;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Szilamér Korodi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Medicine and Pharmacy of Tirgu Mures, Romania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardio Med Medical Center</name>
      <address>
        <city>Targu Mures</city>
        <state>Mures</state>
        <zip>540102</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>July 30, 2022</last_update_submitted>
  <last_update_submitted_qc>July 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial fibrillation recurrence</keyword>
  <keyword>atrial volume</keyword>
  <keyword>atrial fibrosis</keyword>
  <keyword>epicardial adipose tissue</keyword>
  <keyword>inflammatory biomarkers</keyword>
  <keyword>late gadolinium-enhancement cardiac magnetic resonance</keyword>
  <keyword>pulmonary vein isolation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication will be available for interested parties.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The IPD sharing frame is starting 6 months after publication.</ipd_time_frame>
  </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/NCT03757741
org study id: CM0318-FIR
nct id: NCT03757741
lead sponsor: 
collaborator: 
collaborator: 
FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis
      on the risk of recurrence after successful ablation of atrial fibrillation. The level of
      systemic inflammation in the pre-ablation and immediate post-ablation period will be assessed
      on the basis of serum levels of inflammatory biomarkers (hs-CRP, matrix metalloproteases,
      interleukin-6), while the level of cardiac fibrosis will be determined based on MRI imaging
      associated with complex post-processing techniques for mapping myocardial fibrosis at the
      level of left atrium and left ventricle. At the same time, the amount of epicardial fat will
      serve as an indirect marker of localized inflammation and will be determined at different
      levels in the heart (surrounding left atrium, right atrium or the entire heart), while
      ventricular function will be assessed on the basis of serum levels of NT pro-BNP prior to the
      procedure. All these parameters will be investigated in patients with successful ablation of
      AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at
      1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the
      following biomarkers will be determined: serum levels of inflammatory biomarkers and
      NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the
      level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial
      fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.

      The primary endpoint of the study will be represented by the rate of AF recurrence at 1-year
      post ablation, documented by either ECG or Holter monitoring.

      The secondary endpoints of the study will be:

        -  rate of re-hospitalization

        -  rate of survival without relapse

        -  rate of major adverse cardiovascular events (MACE rate, including cardiovascular death
           or stroke)
The prevalence of atrial fibrillation (AF) is on the rise, being the most frequent sustained
      supraventricular arrhythmia and a health issue by its increased morbidity and mortality. In
      most of the cases, myocardial tissue located at the level of the pulmonary veins represents
      the trigger for atrial fibrillation. The pathophysiology of AF is still incompletely
      understood, several studies suggesting that profibrotic and inflammatory processes have a
      crucial role in the development of AF. So far the success rate of AF ablation is not very
      high, reaching 70% in patients with paroxysmal AF and 50% in cases with persistent AF.
      Several risk factors for the occurrence and recurrence of AF have been described in the
      literature, including left atrial enlargement, left ventricular dysfunction, epicardial fat
      volume, and myocardial fibrosis caused by local atrial inflammation. What remains to be
      investigated is the relationship between these risk factors and the recurrence of AF after
      radiofrequency catheter ablation using advanced 3D mapping system.

      This is a clinical prospective, descriptive, single-center study which will be carried out in
      the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed Tirgu Mures, Romania.
      The duration of the study is 2 years which include the initial screening and the follow-up
      period for the recurrence of AF.

      The study will include 100 subjects suitable for catheter ablation. Imaging biomarkers and
      laboratory analyses such as high sensitive C Reactive Protein (hsCRP), matrix
      metalloproteases (MMP), interleukin-6 (IL6) and N-Terminal Pro-B-Type Natriuretic Peptide (NT
      pro-BNP) will be determined in the first 24 hours after the procedure. The anatomy of
      pulmonary veins, atrial fibrosis, atrial volumes and the amount of epicardial fat will be
      evaluated and quantified with late gadolinium-enhancement cardiac magnetic resonance
      (LGE-CMR). All these parameters will be investigated in patients with successful ablation of
      AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at
      1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the
      following biomarkers will be determined: serum levels of inflammatory biomarkers and
      NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the
      level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial
      fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.

      The study will be conducted over a period of 2 years, in which patients will be examined at
      baseline, and will be followed-up for recurrence of AF.

      All patients will sign an informed written consent and will be checked for the exclusion
      criteria prior to enrolment.

      Study objectives:

      Primary: To investigate the correlation between imaging markers provided by cardiac magnetic
      resonance (including the degree of left atrial and ventricular fibrosis, left and right
      atrial volume, epicardial fat tissue volume), inflammatory biomarkers, and the risk of AF
      recurrence post ablation.

      Secondary: To investigate the correlation between structural remodeling of the left and right
      atrium, epicardial fat tissue volume and serum inflammatory biomarkers in patients with AF.

      Study Timeline:

        -  Baseline (day 0)

        -  Obtain and document consent from participant on study consent form.

        -  Verify inclusion/exclusion criteria.

        -  Obtain demographic information, medical history, medication history, alcohol, and
           tobacco use history.

        -  Record results of physical examinations and 12-lead ECG.

        -  Collect blood specimens (complete blood count, biochemistry and inflammatory
           biomarkers).

        -  Imaging procedures: transthoracic 2-D echocardiography, late gadolinium-enhancement
           cardiac magnetic resonance

        -  Visit 1 (month 1,3,6,12)

        -  Record results of physical examinations, 12-lead ECG and medical history.

        -  Imaging procedures: transthoracic 2-D echocardiography

        -  Final study visit (month 12)

        -  Record results of physical examinations, medical history,12-lead ECG and determination
           of serum levels of inflammatory biomarkers and NT-proBNP

        -  Imaging procedures: transthoracic 2-D echocardiography

        -  End-point evaluation.

      Study procedures:

        -  Medical history, clinical examination, laboratory tests (complete blood count,
           biochemistry, serum level of hs-CRP, MMP, IL6, and NT-pro-BNP);

        -  12-lead ECG

        -  2D transthoracic echocardiography with measurement of cardiac diameters, volumes,
           valvular function and regurgitation, pressure gradients, left ventricular systolic and
           diastolic function and ejection fraction.

        -  Late Gadolinium-Enhancement Cardiac Magnetic Resonance (LGE-CMR) with the evaluation of
           left and right atrial volume, the volume of epicardial adipose tissue, the degree of
           atrial and ventricular fibrosis

        -  Pulmonary vein isolation radiofrequency ablation with advanced 3D mapping system

      Data collection: All the information will be collected in a database that consists of
      patient's background, medical history, medication, imaging features provided by cardiac
      ultrasound, Cardiac magnetic resonance and CMR imaging post-processing.
observational model: Cohort
time perspective: Prospective
measure: The rate of AF recurrence after pulmonary vein isolation
time frame: 12 months
description: The primary outcome measure will be represented by the rate of AF recurrence at 1 year post ablation, documented by either ECG or Holter monitoring.
measure: Rate of re-hospitalization
time frame: 12 months
description: The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
measure: Rate of survival without relapse
time frame: 12 months
description: The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
measure: Rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
time frame: 12 months
description: The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
arm group label: AF-SG 01
description: Study subjects with atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation
arm group label: AF-SG 02
description: Study subjects without atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation
intervention type: Diagnostic Test
intervention name: Cardiac imaging tests
description: 2D transthoracic echocardiography; Late gadolinium-enhancement cardiac magnetic resonance with the evaluation of pulmonary veins anatomy, atrial fibrosis, atrial volumes and the amount of epicardial fat will
arm group label: AF-SG 01
arm group label: AF-SG 02
intervention type: Diagnostic Test
intervention name: Venous blood samle collection
description: Venous blood sample collection 1 day prior to the ablation procedure: Serum levels of high sensitive C Reactive Protein, Matrix metalloproteases, Interleukin-6, and N-Terminal Pro-B-Type Natriuretic Peptide.
arm group label: AF-SG 01
arm group label: AF-SG 02
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Szilamér Korodi, M.D.
role: Principal Investigator
affiliation: University of Medicine and Pharmacy of Tirgu Mures, Romania
facility: 
country: Romania
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Fibrosis
mesh term: Inflammation
mesh term: Recurrence
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication will be available for interested parties.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The IPD sharing frame is starting 6 months after publication.