<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/NCT03793998</url>
  </required_header>
  <id_info>
    <org_study_id>Protocollo n. 89 (17/04/2018)</org_study_id>
    <nct_id>NCT03793998</nct_id>
  </id_info>
  <brief_title>Catheter Ablation of Arrhythmias With High Density Mapping System in the Real World Practice.</brief_title>
  <acronym>CHARISMA</acronym>
  <official_title>Catheter Ablation of Arrhythmias With High Density Mapping System in the Real World Practice. The CHARISMA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Pugliese Ciaccio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera Pugliese Ciaccio</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The CHARISMA study is a non-randomized, multicenter, prospective study in which consecutive&#xD;
      patients indicated for arrhythmia will be enrolled.&#xD;
&#xD;
      Patients can be treated with any market released catheter for ablation and diagnostic&#xD;
      examination. The decision to perform the ablation will be made based on clinical evaluation&#xD;
      of the investigators according to their clinical practice. The study does not require&#xD;
      specific surgical techniques. The study has been designed to describe the Italian clinical&#xD;
      practice in relation to the ablation approach of different kind of arrhythmias. In&#xD;
      particular, the investigators will analyze the percentage of acute and long-term success in&#xD;
      clinical practice, predictors of arrhythmias recurrence and they will describe the methods&#xD;
      for the validation of ablation success, the techniques adopted, and the patient management&#xD;
      approaches in the participating centers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2023</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>Percentage of patients with arrhythmia recurrences</measure>
    <time_frame>12 months</time_frame>
    <description>The primary outcome measure of this study is to estimate, after 12-months from the procedure, the percentage of patients with documented arrhythmia recurrences, recognized with the registration of at least 30 seconds of the same arrhythmias with 24h Holter ECG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of acute procedural success of arrhythmias ablation</measure>
    <time_frame>within 30 minutes after ablation procedure</time_frame>
    <description>This secondary outcome measures the percentage of acute procedural success. The acute success of the arrhythmias ablation is verified by; the completion of the necessary ablation application(s), the validation of ablation through appropriate technique(s) and, when applicable, the termination of the primary arrhythmia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline patient's characteristic (clinical history and drug therapy) for subjects undergoing catheter ablation</measure>
    <time_frame>within 30 minutes after ablation procedure</time_frame>
    <description>This secondary outcome measures the baseline patient's characteristics (clinical history and drug therapy) as potential predictors of acute success</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of new onset of different arrhythmias (from the primary one)</measure>
    <time_frame>12 months</time_frame>
    <description>This secondary outcome measures the rate of new onset of any kind of different arrhythmia (from the primary one) related to the primary ablation procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary arrhythmia recurrences and association with the baseline patient's characteristics (clinical history and drug therapy)</measure>
    <time_frame>36 months</time_frame>
    <description>This secondary outcome measure of this study is to evaluate baseline patient's characteristics as potential predictors of primary arrhythmia recurrences, that will be evaluated at 12 months and 36 months follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall procedure time</measure>
    <time_frame>Intraoperative</time_frame>
    <description>This secondary outcome measures the radiofrequency delivery time, the total ablation time, the fluoroscopy time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of the adverse events associated with the primary ablation procedure</measure>
    <time_frame>12 months</time_frame>
    <description>This secondary outcome measures the rate of the adverse events that occurs during the procedure and after 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate costs related to the use of health care resources</measure>
    <time_frame>60 months</time_frame>
    <description>This secondary outcome measures the resource consumption and the associated costs in term of ablation procedures, follow-up, management of complication and health care resources utilization</description>
  </secondary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Cardiac Arrhythmias</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients, clinically indicated for arrhythmias ablation, will be enrolled&#xD;
        after signing an informed consent form and an authorization to use and disclose health&#xD;
        information&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are eligible for ablation procedure of atrial and ventricular arrhythmia;&#xD;
&#xD;
          -  Patients who are able to sign an authorization to use and disclose health information&#xD;
             and capable of providing informed consent.&#xD;
&#xD;
          -  Patients who are willing and capable to attend scheduled follow-up visits at the&#xD;
             clinical investigational center for at least 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are currently enrolled in another clinical study that would directly&#xD;
             interfere with the clinical practice of the investigational center&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giampiero Maglia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliera Pugliese Ciaccio</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Giampiero Maglia, MD</last_name>
    <phone>0039 0963 531325</phone>
    <email>clinical-charisma@eleva-hosting.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Azienda Ospedaliera Pugliese-Ciaccio</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giampiero Maglia, MD</last_name>
    </contact>
    <investigator>
      <last_name>Giampiero Maglia, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera Pugliese Ciaccio</investigator_affiliation>
    <investigator_full_name>Giampiero Maglia</investigator_full_name>
    <investigator_title>Head of Electrophysiology and Cardiac Pacing</investigator_title>
  </responsible_party>
  <keyword>Cardiac Catheter Ablation</keyword>
  <keyword>Cardiac Arrhythmias</keyword>
  <keyword>Mapping System</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</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/NCT03793998
org study id: Protocollo n. 89 (17/04/2018)
nct id: NCT03793998
lead sponsor: 
has dmc: No
is fda regulated drug: No
The CHARISMA study is a non-randomized, multicenter, prospective study in which consecutive
      patients indicated for arrhythmia will be enrolled.

      Patients can be treated with any market released catheter for ablation and diagnostic
      examination. The decision to perform the ablation will be made based on clinical evaluation
      of the investigators according to their clinical practice. The study does not require
      specific surgical techniques. The study has been designed to describe the Italian clinical
      practice in relation to the ablation approach of different kind of arrhythmias. In
      particular, the investigators will analyze the percentage of acute and long-term success in
      clinical practice, predictors of arrhythmias recurrence and they will describe the methods
      for the validation of ablation success, the techniques adopted, and the patient management
      approaches in the participating centers
observational model: Cohort
time perspective: Prospective
measure: Percentage of patients with arrhythmia recurrences
time frame: 12 months
description: The primary outcome measure of this study is to estimate, after 12-months from the procedure, the percentage of patients with documented arrhythmia recurrences, recognized with the registration of at least 30 seconds of the same arrhythmias with 24h Holter ECG
measure: The percentage of acute procedural success of arrhythmias ablation
time frame: within 30 minutes after ablation procedure
description: This secondary outcome measures the percentage of acute procedural success. The acute success of the arrhythmias ablation is verified by; the completion of the necessary ablation application(s), the validation of ablation through appropriate technique(s) and, when applicable, the termination of the primary arrhythmia.
measure: Baseline patient's characteristic (clinical history and drug therapy) for subjects undergoing catheter ablation
time frame: within 30 minutes after ablation procedure
description: This secondary outcome measures the baseline patient's characteristics (clinical history and drug therapy) as potential predictors of acute success
measure: Rate of new onset of different arrhythmias (from the primary one)
time frame: 12 months
description: This secondary outcome measures the rate of new onset of any kind of different arrhythmia (from the primary one) related to the primary ablation procedure
measure: Primary arrhythmia recurrences and association with the baseline patient's characteristics (clinical history and drug therapy)
time frame: 36 months
description: This secondary outcome measure of this study is to evaluate baseline patient's characteristics as potential predictors of primary arrhythmia recurrences, that will be evaluated at 12 months and 36 months follow up
measure: Overall procedure time
time frame: Intraoperative
description: This secondary outcome measures the radiofrequency delivery time, the total ablation time, the fluoroscopy time
measure: Rate of the adverse events associated with the primary ablation procedure
time frame: 12 months
description: This secondary outcome measures the rate of the adverse events that occurs during the procedure and after 12 months
measure: Estimate costs related to the use of health care resources
time frame: 60 months
description: This secondary outcome measures the resource consumption and the associated costs in term of ablation procedures, follow-up, management of complication and health care resources utilization
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Giampiero Maglia, MD
role: Principal Investigator
affiliation: Azienda Ospedaliera Pugliese Ciaccio
last name: Giampiero Maglia, MD
phone: 0039 0963 531325
email: clinical-charisma@eleva-hosting.it
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Pugliese Ciaccio
investigator full name: Giampiero Maglia
investigator title: Head of Electrophysiology and Cardiac Pacing
mesh term: Arrhythmias, Cardiac