<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/NCT04504591</url>
  </required_header>
  <id_info>
    <org_study_id>DE-08-16</org_study_id>
    <nct_id>NCT04504591</nct_id>
  </id_info>
  <brief_title>Validation Of A New S-ICD Algorithm To Reduce Oversensing Of Dynamic T-Waves In Patients With Brugada Syndrome</brief_title>
  <acronym>DE-08-16</acronym>
  <official_title>Validation Of A New S-ICD Algorithm To Reduce Oversensing Of Dynamic T-Waves In Patients With Brugada Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Angelo Auricchio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiocentro Ticino</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 main objective of this study will be to assess the efficacy of S-ICD with SMART Pass to&#xD;
      discriminate dynamic T-waves amplitudes and morphologies over time.&#xD;
&#xD;
      Pilot, multi-centric, prospective, blinded, one arm (repeated measures), non-interventional&#xD;
      study. Objective is to setup a 8-center data collection registry between Switzerland, Italy&#xD;
      and Belgium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subcutaneous implantable cardioverter-defibrillator (S-ICD) should be considered as an&#xD;
      alternative to transvenous defibrillators in patients with an ICD indication when pacing&#xD;
      therapy for bradycardia support, cardiac resynchronization or ventricular tachycardia&#xD;
      management is not necessary.1 This class IIa recommendation from the 2015 ESC guidelines can&#xD;
      often be applied to patients with inherited channelopathies, since these patients usually&#xD;
      require decades of ICD therapy without developing a need for any type of pacing support. On&#xD;
      the other hand, especially in patients with Brugada Syndrome (BrS), the dynamic nature of ECG&#xD;
      morphology may increase the risk for cardiac T-wave oversensing (TWOS), which has also been&#xD;
      reported the main cause of inappropriate shocks (IAS) in the general S-ICD population. In&#xD;
      order to avoid unnecessary sensing issues with the S-ICD, baseline ECG screening is&#xD;
      recommended prior to the implantation procedure. Recently, it has been shown that eligibility&#xD;
      failure for S-ICD can occur in up to 13% of patients with an inherited primary arrhythmia&#xD;
      syndrome and that patients with BrS present the highest rate of screening failure if compared&#xD;
      with other channelopathies.&#xD;
&#xD;
      As of yet, this QRS and T-wave morphology assessment can be done with an algorithm-based&#xD;
      automated screening tool (AST) that mimics the sensing set-up process of the S-ICD after&#xD;
      implant.&#xD;
&#xD;
      Recently, a novel 9Hz high-pass filter (SMART Pass, available for all EMBLEM S-ICD models)&#xD;
      has been introduced to reduce the risk of TWOS with the S-ICD12. This algorithm is only&#xD;
      available with the S-ICD sensing mechanism and has not been incorporated in the automated&#xD;
      screening software12. Retrospective modelling of inappropriate shock events recorded in the&#xD;
      EFFORTLESS registry have shown a reduction in inappropriate shocks by ~80% with SMART Pass&#xD;
      compared to the first generation sensing algorithm of the S-ICD13. This was achieved without&#xD;
      affecting the detection and the time to therapy for true ventricular arrhythmias.&#xD;
&#xD;
      Prospective data are lacking about the effectiveness of SMART Pass to discriminate T-waves in&#xD;
      patients with dynamic ECG morphologies. This may be of particular interest since the&#xD;
      occurrence of ECG morphology disturbances is usually difficult to be predicted in individual&#xD;
      patients. As such, these data will provide additional guidance to the mandatory screening&#xD;
      process for all S-ICD candidates, in particular for those who have a known risk factor for&#xD;
      dynamic ECG changes, like patients withBrS. The main objective of this study will be to&#xD;
      assess the efficacy of S-ICD with SMART Pass to discriminate dynamic T-waves amplitudes and&#xD;
      morphologies over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Early termination due to COVID19; preliminary data can be considered significant&#xD;
  </why_stopped>
  <start_date type="Actual">December 14, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of S-ICD screening failure due to TWOS with and without SMART Pass in patients with ajmaline-induced Brugada Type I ECG.</measure>
    <time_frame>through study completion, an average of 15 months</time_frame>
    <description>Rate of S-ICD screening failure due to TWOS after ajmaline challenge with and without SMART Pass in patients with Ajmaline induced Brugada type I ECG.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of S-ICD screening failure with and without SMART Pass in the patients without ajmaline-induced Brugada type-I ECG who manifest a conduction disturbance (i.e. RBBB).</measure>
    <time_frame>through study completion, an average of 15 months</time_frame>
    <description>Rate of S-ICD screening failure due to TWOS after ajmaline challenge with and without SMART Pass in patients without Brugada type I EC but with Ajmaline induced ECG conduction disturbances.</description>
  </secondary_outcome>
  <enrollment type="Actual">126</enrollment>
  <condition>Brugada Syndrome 1S</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients with suspected BrS will be submitted for routine diagnostic ajmaline&#xD;
        testing.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and/or female subjects beyond the ages of ≥18 the time of informed consent;&#xD;
&#xD;
          2. Subjects with suspected BrS;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of baseline Brugada type I ECG&#xD;
&#xD;
          2. Presence of structural cardiac abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Consecutive patients with suspected BrS will be submitted for routine diagnostic ajmaline testing</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giulio Conte, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione Cardiocentro Ticino</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ-VUB Brussels</name>
      <address>
        <city>Brussels</city>
        <zip>B1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Brotzu</name>
      <address>
        <city>Cagliari</city>
        <zip>09134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ATS Sardegna Ospedale San Francesco-ASSL 3 NUORO</name>
      <address>
        <city>Nuoro</city>
        <zip>08100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione I.R.C.C.S. Policlinico San Matteo di Pavia</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Genève</name>
      <address>
        <city>Genève</city>
        <zip>CH - 1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Cardiocentro Ticino</name>
      <address>
        <city>Lugano</city>
        <zip>CH-6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cardiocentro Ticino</investigator_affiliation>
    <investigator_full_name>Angelo Auricchio</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brugada Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT04504591
org study id: DE-08-16
nct id: NCT04504591
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main objective of this study will be to assess the efficacy of S-ICD with SMART Pass to
      discriminate dynamic T-waves amplitudes and morphologies over time.

      Pilot, multi-centric, prospective, blinded, one arm (repeated measures), non-interventional
      study. Objective is to setup a 8-center data collection registry between Switzerland, Italy
      and Belgium.
The subcutaneous implantable cardioverter-defibrillator (S-ICD) should be considered as an
      alternative to transvenous defibrillators in patients with an ICD indication when pacing
      therapy for bradycardia support, cardiac resynchronization or ventricular tachycardia
      management is not necessary.1 This class IIa recommendation from the 2015 ESC guidelines can
      often be applied to patients with inherited channelopathies, since these patients usually
      require decades of ICD therapy without developing a need for any type of pacing support. On
      the other hand, especially in patients with Brugada Syndrome (BrS), the dynamic nature of ECG
      morphology may increase the risk for cardiac T-wave oversensing (TWOS), which has also been
      reported the main cause of inappropriate shocks (IAS) in the general S-ICD population. In
      order to avoid unnecessary sensing issues with the S-ICD, baseline ECG screening is
      recommended prior to the implantation procedure. Recently, it has been shown that eligibility
      failure for S-ICD can occur in up to 13% of patients with an inherited primary arrhythmia
      syndrome and that patients with BrS present the highest rate of screening failure if compared
      with other channelopathies.

      As of yet, this QRS and T-wave morphology assessment can be done with an algorithm-based
      automated screening tool (AST) that mimics the sensing set-up process of the S-ICD after
      implant.

      Recently, a novel 9Hz high-pass filter (SMART Pass, available for all EMBLEM S-ICD models)
      has been introduced to reduce the risk of TWOS with the S-ICD12. This algorithm is only
      available with the S-ICD sensing mechanism and has not been incorporated in the automated
      screening software12. Retrospective modelling of inappropriate shock events recorded in the
      EFFORTLESS registry have shown a reduction in inappropriate shocks by ~80% with SMART Pass
      compared to the first generation sensing algorithm of the S-ICD13. This was achieved without
      affecting the detection and the time to therapy for true ventricular arrhythmias.

      Prospective data are lacking about the effectiveness of SMART Pass to discriminate T-waves in
      patients with dynamic ECG morphologies. This may be of particular interest since the
      occurrence of ECG morphology disturbances is usually difficult to be predicted in individual
      patients. As such, these data will provide additional guidance to the mandatory screening
      process for all S-ICD candidates, in particular for those who have a known risk factor for
      dynamic ECG changes, like patients withBrS. The main objective of this study will be to
      assess the efficacy of S-ICD with SMART Pass to discriminate dynamic T-waves amplitudes and
      morphologies over time.
observational model: Other
time perspective: Prospective
measure: Rate of S-ICD screening failure due to TWOS with and without SMART Pass in patients with ajmaline-induced Brugada Type I ECG.
time frame: through study completion, an average of 15 months
description: Rate of S-ICD screening failure due to TWOS after ajmaline challenge with and without SMART Pass in patients with Ajmaline induced Brugada type I ECG.
measure: Rate of S-ICD screening failure with and without SMART Pass in the patients without ajmaline-induced Brugada type-I ECG who manifest a conduction disturbance (i.e. RBBB).
time frame: through study completion, an average of 15 months
description: Rate of S-ICD screening failure due to TWOS after ajmaline challenge with and without SMART Pass in patients without Brugada type I EC but with Ajmaline induced ECG conduction disturbances.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Consecutive patients with suspected BrS will be submitted for routine diagnostic ajmaline testing
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giulio Conte, Dr.
role: Principal Investigator
affiliation: Fondazione Cardiocentro Ticino
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Italy
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Cardiocentro Ticino
investigator full name: Angelo Auricchio
investigator title: Prof.
mesh term: Brugada Syndrome
mesh term: Syndrome