<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/NCT01665131</url>
  </required_header>
  <id_info>
    <org_study_id>SUBTRACT 1</org_study_id>
    <nct_id>NCT01665131</nct_id>
  </id_info>
  <brief_title>The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs</brief_title>
  <acronym>SUBTRACT</acronym>
  <official_title>The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Implantable cardiac defibrillators (ICDs) are devices that are put into patients at high risk&#xD;
      of sudden cardiac death. They are used to treat life threatening heart rhythm disorders. They&#xD;
      have conventionally consisted of a generator sitting under the skin of the chest and leads&#xD;
      which pass from veins in the collar bone region to the heart. Problems with these devices can&#xD;
      necessitate extraction, with the commonest reason being infection. If extraction is required&#xD;
      for infection then re-implantation is usually deferred for approximately one week whilst&#xD;
      antibiotics are given so that the risk of infection of the new device can be minimised. This&#xD;
      has considerable implications for healthcare resources. A new ICD has been developed that is&#xD;
      entirely subcutaneous with no intravenous element. It is already in clinical use and is&#xD;
      positioned remote from conventional ICD sites. With no intravenous element there is very&#xD;
      little risk of infection in the blood affecting the new device. It is therefore likely to be&#xD;
      possible to re-implant these devices immediately after extracting a conventional system. The&#xD;
      aim of this research is to assess the outcome in patients re-implanted with this device&#xD;
      immediately after conventional ICD system extraction. This data will be compared compared to&#xD;
      those who have conventional systems re-implanted after the necessary delay.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">November 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of hospital stay</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of ICD infection</measure>
    <time_frame>1 year</time_frame>
    <description>To see what the infection rate of new implants is and to assess how this compares to published rates of infection when using the standard method.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Use of Subcutaneous ICDs Following Infection</condition>
  <arm_group>
    <arm_group_label>Subcutaneous ICD group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cameron Health S-ICD SQ-RX</intervention_name>
    <arm_group_label>Subcutaneous ICD group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients fulfilling conventional criteria for ICD extraction and who require&#xD;
             implantation of a further ICD without a need for pacing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Indication for anti-bradycardia pacing or cardiac resynchronisation therapy&#xD;
&#xD;
          -  Life expectancy &lt; 1 year&#xD;
&#xD;
          -  Need for intravenous inotropes&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher A Rinaldi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 13, 2012</last_update_submitted>
  <last_update_submitted_qc>August 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guy's and St Thomas' NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Manav Sohal</investigator_full_name>
    <investigator_title>Clinical Research Fellow</investigator_title>
  </responsible_party>
  <!-- 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/NCT01665131
org study id: SUBTRACT 1
nct id: NCT01665131
lead sponsor: 
has dmc: Yes
Implantable cardiac defibrillators (ICDs) are devices that are put into patients at high risk
      of sudden cardiac death. They are used to treat life threatening heart rhythm disorders. They
      have conventionally consisted of a generator sitting under the skin of the chest and leads
      which pass from veins in the collar bone region to the heart. Problems with these devices can
      necessitate extraction, with the commonest reason being infection. If extraction is required
      for infection then re-implantation is usually deferred for approximately one week whilst
      antibiotics are given so that the risk of infection of the new device can be minimised. This
      has considerable implications for healthcare resources. A new ICD has been developed that is
      entirely subcutaneous with no intravenous element. It is already in clinical use and is
      positioned remote from conventional ICD sites. With no intravenous element there is very
      little risk of infection in the blood affecting the new device. It is therefore likely to be
      possible to re-implant these devices immediately after extracting a conventional system. The
      aim of this research is to assess the outcome in patients re-implanted with this device
      immediately after conventional ICD system extraction. This data will be compared compared to
      those who have conventional systems re-implanted after the necessary delay.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Length of hospital stay
measure: Rate of ICD infection
time frame: 1 year
description: To see what the infection rate of new implants is and to assess how this compares to published rates of infection when using the standard method.
arm group label: Subcutaneous ICD group
arm group type: Experimental
intervention type: Device
intervention name: Cameron Health S-ICD SQ-RX
arm group label: Subcutaneous ICD group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Christopher A Rinaldi, MD
role: Principal Investigator
affiliation: Guy's and St Thomas' NHS Foundation Trust
responsible party type: Principal Investigator
investigator affiliation: Guy's and St Thomas' NHS Foundation Trust
investigator full name: Manav Sohal
investigator title: Clinical Research Fellow