<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/NCT03304847</url>
  </required_header>
  <id_info>
    <org_study_id>IRCCSDonato 01-Cardiomyopathy</org_study_id>
    <nct_id>NCT03304847</nct_id>
  </id_info>
  <brief_title>Arrhythmogenic Substrate in Primary Cardiomyopathies and/or Channellopathies</brief_title>
  <official_title>Arrhythmogenic Substrate Assessment in Patients With Primary Cardiomyopathies and/or Channellopaties With and Without History of Brugada Syndrome: A Prospective Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Donato</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Policlinico S. Donato</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study assesses the value of arrhythmogenic substrate identification and elimination by&#xD;
      catheter ablation to prevent recurrent ventricular arrhythmias and sudden cardiac death in a&#xD;
      series of selected patients with primary cardiomyopathy and/or channellopaties with ICD&#xD;
      implantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study is designed as a prospective single center study. All selected patients&#xD;
      with implanted ICD to prevent VT/VF recurrence who are referred to the Arrhythmology&#xD;
      Department of San Donato Milanese Hospital, for the management of a primary cardiomyopathy&#xD;
      fulfilling the inclusion criteria will be enrolled. Primary cardiomyopathies include: -&#xD;
      dilated cardiomyopathy (DCM), - arrhythmogenic right ventricular cardiomyopathy (ARVC), -&#xD;
      left ventricular non-compaction (LVNC), - early repolarization syndrome (ER), and -&#xD;
      hypertrophic cardiomyopathy (HCM).Channellopaties incude - Long QT syndrome and J-wave&#xD;
      syndrome) Patients with or without a family history of BrS, will also be included.&#xD;
      Endo-epicardial electroanatomical 3Dmapping and RFA ablation will be systematically performed&#xD;
      according to a standardized procedure. Patients will be monitored for at least 3 days after&#xD;
      RF ablation. Before hospital discharge, echocardiography and 12-lead ECG will be performed.&#xD;
      Patients will be followed-up clinically after the procedure as per normal clinical practice.&#xD;
      Follow-up visits will be systematically scheduled at 3, 6, 12, 18 and 24 months. 12-lead ECG&#xD;
      and ICD interrogation will be performed at each follow-up visit. Patients will be instructed&#xD;
      to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias.&#xD;
      Documentation for intercurrent events will be requested and collected. The maximal duration&#xD;
      of study participation for the individual patients is two years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 24, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>single group assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from ventricular fibrillation or ventricular tachycardia</measure>
    <time_frame>two years</time_frame>
    <description>Survival from recurrent ventricular arrhythmias</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurements of Areas of prolonged ventricular potentials obtained by electroamatomocal maps before and after ablation</measure>
    <time_frame>1 day</time_frame>
    <description>Electrophysiological characterization of the arrhythmogenic substrate by electroanatomical maps</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>Ablation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Radio-frequency catheter ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ablation</intervention_name>
    <description>radio-frequency applications on arrhythmogenic substrate</description>
    <arm_group_label>Ablation</arm_group_label>
    <other_name>radio-frequency ablation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients affected by cardiomyopathies and/or channellopaties (long QT syndrome and&#xD;
             J-wave syndrome) with and without documented family history of BrS;&#xD;
&#xD;
          -  Presence of symptoms attributable to VA and/or presenting documented arrhythmic&#xD;
             episodes;&#xD;
&#xD;
          -  Patients with an ICD already implanted;&#xD;
&#xD;
          -  Patients referred to the centre for an electrophysiological study and indication for a&#xD;
             potential concomitant radio-frequency catheter ablation (RFA) of ventricular&#xD;
             tachycardia (VT) or ventricular fibrillation (VF);&#xD;
&#xD;
          -  Age ≥ 18;&#xD;
&#xD;
          -  Willingness to attend follow-up examinations;&#xD;
&#xD;
          -  Written informed consent for the participation in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breast-feeding;&#xD;
&#xD;
          -  Life expectancy &lt; 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlo Pappone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chief of Arrhythmology Department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carlo Pappone, MD</last_name>
    <phone>+39 02 52774260</phone>
    <email>carlo.pappone@af-ablation.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>IRCCS Policlinico S. Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <state>Milano</state>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlo Pappone, MD, PhD</last_name>
      <phone>00390252774260</phone>
      <email>carlo.pappone@af-ablation.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Donato</investigator_affiliation>
    <investigator_full_name>Carlo Pappone</investigator_full_name>
    <investigator_title>Chief of Arrhythmology Deartment</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03304847
org study id: IRCCSDonato 01-Cardiomyopathy
nct id: NCT03304847
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study assesses the value of arrhythmogenic substrate identification and elimination by
      catheter ablation to prevent recurrent ventricular arrhythmias and sudden cardiac death in a
      series of selected patients with primary cardiomyopathy and/or channellopaties with ICD
      implantation.
The present study is designed as a prospective single center study. All selected patients
      with implanted ICD to prevent VT/VF recurrence who are referred to the Arrhythmology
      Department of San Donato Milanese Hospital, for the management of a primary cardiomyopathy
      fulfilling the inclusion criteria will be enrolled. Primary cardiomyopathies include: -
      dilated cardiomyopathy (DCM), - arrhythmogenic right ventricular cardiomyopathy (ARVC), -
      left ventricular non-compaction (LVNC), - early repolarization syndrome (ER), and -
      hypertrophic cardiomyopathy (HCM).Channellopaties incude - Long QT syndrome and J-wave
      syndrome) Patients with or without a family history of BrS, will also be included.
      Endo-epicardial electroanatomical 3Dmapping and RFA ablation will be systematically performed
      according to a standardized procedure. Patients will be monitored for at least 3 days after
      RF ablation. Before hospital discharge, echocardiography and 12-lead ECG will be performed.
      Patients will be followed-up clinically after the procedure as per normal clinical practice.
      Follow-up visits will be systematically scheduled at 3, 6, 12, 18 and 24 months. 12-lead ECG
      and ICD interrogation will be performed at each follow-up visit. Patients will be instructed
      to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias.
      Documentation for intercurrent events will be requested and collected. The maximal duration
      of study participation for the individual patients is two years.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single group assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from ventricular fibrillation or ventricular tachycardia
time frame: two years
description: Survival from recurrent ventricular arrhythmias
measure: Measurements of Areas of prolonged ventricular potentials obtained by electroamatomocal maps before and after ablation
time frame: 1 day
description: Electrophysiological characterization of the arrhythmogenic substrate by electroanatomical maps
arm group label: Ablation
arm group type: Other
description: Radio-frequency catheter ablation
intervention type: Other
intervention name: ablation
description: radio-frequency applications on arrhythmogenic substrate
arm group label: Ablation
other name: radio-frequency ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlo Pappone, MD
role: Principal Investigator
affiliation: Chief of Arrhythmology Department
last name: Carlo Pappone, MD
phone: +39 02 52774260
email: carlo.pappone@af-ablation.org
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Donato
investigator full name: Carlo Pappone
investigator title: Chief of Arrhythmology Deartment
mesh term: Cardiomyopathies
sharing ipd: No