<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/NCT03271619</url>
  </required_header>
  <id_info>
    <org_study_id>13/SC/0427</org_study_id>
    <nct_id>NCT03271619</nct_id>
  </id_info>
  <brief_title>Electrical Safety of Implantable Cardioverter Defibrillators</brief_title>
  <official_title>Electrical Safety of Rescuers in Contact With Patients During Implanted Cardioverter Defibrillator Discharge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Southampton NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</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>
      Patients at risk of developing life-threatening heart rhythms may require the implantation of&#xD;
      a small device called a cardioverter-defibrillator (ICD), which constantly monitors the heart&#xD;
      rhythm and delivers an electrical shock to the heart when indicated, in order to return the&#xD;
      heart back to a normal rhythm. Many thousands of these devices have been implanted and are&#xD;
      electrically active in patients who collapse and need resuscitation.&#xD;
&#xD;
      When a patient with an ICD collapses, the device may discharge without warning while a&#xD;
      rescuer is performing external chest compressions (cardiac massage). Conventional ICDs placed&#xD;
      below the left collar bone typically deliver 35-50 J energy when they discharge, but newer&#xD;
      ICDs placed under the skin (S-ICD) alongside the breastbone deliver a larger energy when&#xD;
      discharging; typically 50-80J energy.&#xD;
&#xD;
      Rescuers performing external chest compressions on a patient during conventional ICD&#xD;
      discharge have reported the sensation of a painful electrical shock and permanent nerve&#xD;
      damage. In these situations, rescuers appear to have been exposed to electrical current from&#xD;
      the ICD considerably in excess of that which is considered a safe threshold.&#xD;
&#xD;
      Studies of surface current resulting from discharge of conventional ICDs have been reported&#xD;
      in excess of 100 mA which is far in excess of the safe 1 mA limit, and puts the rescuer at&#xD;
      considerable risk of tissue damage and possible dangerous heart rhythms. The newer S-ICDs&#xD;
      deliver approximately 50% more energy and have the potential to result in exposure of a&#xD;
      rescuer to even higher currents.&#xD;
&#xD;
      With increasing numbers of the S-ICDs being implanted, and the inevitability that rescuers&#xD;
      will soon find themselves exposed to leakage current from these devices, there is a need to&#xD;
      examine the leakage currents arising from these devices and assess any subsequent risk to a&#xD;
      rescuer performing external chest compressions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale for Study:&#xD;
&#xD;
      When patients undergo elective implantation of an ICD, the device is tested by inducing&#xD;
      ventricular fibrillation (VF) in the patient and allowing the ICD to sense, charge and&#xD;
      discharge in an attempt to shock the patient back into a normal rhythm. This provides a&#xD;
      controlled, elective situation in which to measure the cutaneous current on the patient's&#xD;
      skin which is the current to which a rescuer could potentially be exposed.&#xD;
&#xD;
      By understanding the leakage currents from these devices, the investigators will be able to&#xD;
      better understand the safety of rescuers in contact with patients fitted with an ICD and make&#xD;
      specific recommendations to enable to safe undertaking of uninterrupted external chest&#xD;
      compressions while the ICD may be discharging.&#xD;
&#xD;
      STUDY OBJECTIVES&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      To measure cutaneous leakage current on the chest wall during conventional and S-ICD&#xD;
      discharge.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To make recommendations based on this data regarding the safety of rescuers in contact with a&#xD;
      patient during ICD discharge.&#xD;
&#xD;
      ENDPOINTS&#xD;
&#xD;
      Primary Endpoint:&#xD;
&#xD;
      Maximum cutaneous current measured at multiple sites on the chest wall during ICD discharge.&#xD;
&#xD;
      STUDY DESIGN This is a prospective cohort study, aiming to study sequential patients&#xD;
      undergoing elective ICD implantation and testing over a 12 month period at University&#xD;
      Hospital Southampton.&#xD;
&#xD;
      The patient will undergo elective ICD implantation according to normal protocol. There will&#xD;
      be no change in their treatment. After induction of general anaesthesia, an array of small&#xD;
      self-adhesive electrodes (similar to ECG 'dots') will be placed on the patient's chest wall,&#xD;
      and connected to a multichannel recording device.&#xD;
&#xD;
      After implantation of the ICD, the device will be tested as per normal protocol. VF is&#xD;
      induced in the patient. The ICD senses this arrhythmia, charges and immediately delivers a&#xD;
      shock to the myocardium. As this shock is delivered, the investigators will record the&#xD;
      current reaching the surface electrode array using the multichannel recorder. Most patients&#xD;
      only require one shock as defibrillation rates with ICDs are &gt;90%. If a second shock is&#xD;
      required, the ICD will charge automatically and discharge once again. If this occurs, the&#xD;
      investigators will also measure the cutaneous current at this second, higher energy level.&#xD;
      The study is then concluded. Any subsequent shocks are delivered through external paddles and&#xD;
      the investigators would not require any data from this stage of the procedure.&#xD;
&#xD;
      STUDY POPULATION Number of Participants The investigators aim to assess 20 patients&#xD;
      undergoing conventional ICD implantation and a further 20 patients undergoing S-ICD&#xD;
      implantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>Surface current during defibrillation</measure>
    <time_frame>Approximately 10 mSec as the ICD discharges (i.e. at the time of testing)</time_frame>
    <description>To measure cutaneous leakage current on the chest wall during conventional and S-ICD discharge.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Defibrillators, Implantable</condition>
  <condition>Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Transvenous ICD</arm_group_label>
    <description>Patients with a transvenous ICD undergoing defibrillation testing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subcutaneous ICD</arm_group_label>
    <description>Patients with a subcutaneous ICD undergoing defibrillation testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Surface current measurement</intervention_name>
    <description>Measurement of surface current between electrodes placed on the chest wall during defibrillation</description>
    <arm_group_label>Subcutaneous ICD</arm_group_label>
    <arm_group_label>Transvenous ICD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with implanted defibrillators (ICDs) undergoing defibrillation testing.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with implanted defibrillators (ICDs) undergoing defibrillation testing&#xD;
&#xD;
          -  Patients undergoing ICD implantation that requires a defibrillation test at the end of&#xD;
             the implantation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enrolment in other ICD-related studies&#xD;
&#xD;
          -  Patients &lt;18 yrs age&#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>Charles Deakin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Southampton NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Southampton</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Willcox ME, Prutkin JM, Bardy GH. Recent developments in the subcutaneous ICD. Trends Cardiovasc Med. 2016 Aug;26(6):526-35. doi: 10.1016/j.tcm.2016.03.004. Epub 2016 Mar 15.</citation>
    <PMID>27079889</PMID>
  </reference>
  <reference>
    <citation>Chue CD, Kwok CS, Wong CW, Patwala A, Barker D, Zaidi A, Mamas MA, Cunnington C, Ahmed FZ. Efficacy and safety of the subcutaneous implantable cardioverter defibrillator: a systematic review. Heart. 2017 Sep;103(17):1315-1322. doi: 10.1136/heartjnl-2016-310852. Epub 2017 Jul 7.</citation>
    <PMID>28687562</PMID>
  </reference>
  <reference>
    <citation>Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.</citation>
    <PMID>26477420</PMID>
  </reference>
  <reference>
    <citation>Clements PA. Hazards of performing chest compressions in collapsed patients with internal cardioverter defibrillators. Emerg Med J. 2003 Jul;20(4):379-80. doi: 10.1136/emj.20.4.379. No abstract available.</citation>
    <PMID>12835365</PMID>
  </reference>
  <reference>
    <citation>Stockwell B, Bellis G, Morton G, Chung K, Merton WL, Andrews N, Smith GB. Electrical injury during &quot;hands on&quot; defibrillation-A potential risk of internal cardioverter defibrillators? Resuscitation. 2009 Jul;80(7):832-4. doi: 10.1016/j.resuscitation.2009.04.010. Epub 2009 May 14.</citation>
    <PMID>19446388</PMID>
  </reference>
  <reference>
    <citation>Niwano S, Kojima J, Inuo K, Saito J, Kashiwa T, Suyama M, Toyoshima T, Aizawa Y, Izumi T. Measurement of body surface energy leakage of defibrillation shock by an implantable cardioverter defibrillator. Pacing Clin Electrophysiol. 2002 Aug;25(8):1212-8. doi: 10.1046/j.1460-9592.2002.01212.x.</citation>
    <PMID>12358172</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>January 10, 2018</last_update_submitted>
  <last_update_submitted_qc>January 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Safety Issues</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Please contact researchers directly</ipd_description>
  </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/NCT03271619
org study id: 13/SC/0427
nct id: NCT03271619
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients at risk of developing life-threatening heart rhythms may require the implantation of
      a small device called a cardioverter-defibrillator (ICD), which constantly monitors the heart
      rhythm and delivers an electrical shock to the heart when indicated, in order to return the
      heart back to a normal rhythm. Many thousands of these devices have been implanted and are
      electrically active in patients who collapse and need resuscitation.

      When a patient with an ICD collapses, the device may discharge without warning while a
      rescuer is performing external chest compressions (cardiac massage). Conventional ICDs placed
      below the left collar bone typically deliver 35-50 J energy when they discharge, but newer
      ICDs placed under the skin (S-ICD) alongside the breastbone deliver a larger energy when
      discharging; typically 50-80J energy.

      Rescuers performing external chest compressions on a patient during conventional ICD
      discharge have reported the sensation of a painful electrical shock and permanent nerve
      damage. In these situations, rescuers appear to have been exposed to electrical current from
      the ICD considerably in excess of that which is considered a safe threshold.

      Studies of surface current resulting from discharge of conventional ICDs have been reported
      in excess of 100 mA which is far in excess of the safe 1 mA limit, and puts the rescuer at
      considerable risk of tissue damage and possible dangerous heart rhythms. The newer S-ICDs
      deliver approximately 50% more energy and have the potential to result in exposure of a
      rescuer to even higher currents.

      With increasing numbers of the S-ICDs being implanted, and the inevitability that rescuers
      will soon find themselves exposed to leakage current from these devices, there is a need to
      examine the leakage currents arising from these devices and assess any subsequent risk to a
      rescuer performing external chest compressions.
Rationale for Study:

      When patients undergo elective implantation of an ICD, the device is tested by inducing
      ventricular fibrillation (VF) in the patient and allowing the ICD to sense, charge and
      discharge in an attempt to shock the patient back into a normal rhythm. This provides a
      controlled, elective situation in which to measure the cutaneous current on the patient's
      skin which is the current to which a rescuer could potentially be exposed.

      By understanding the leakage currents from these devices, the investigators will be able to
      better understand the safety of rescuers in contact with patients fitted with an ICD and make
      specific recommendations to enable to safe undertaking of uninterrupted external chest
      compressions while the ICD may be discharging.

      STUDY OBJECTIVES

      Primary Objective:

      To measure cutaneous leakage current on the chest wall during conventional and S-ICD
      discharge.

      Secondary Objectives:

      To make recommendations based on this data regarding the safety of rescuers in contact with a
      patient during ICD discharge.

      ENDPOINTS

      Primary Endpoint:

      Maximum cutaneous current measured at multiple sites on the chest wall during ICD discharge.

      STUDY DESIGN This is a prospective cohort study, aiming to study sequential patients
      undergoing elective ICD implantation and testing over a 12 month period at University
      Hospital Southampton.

      The patient will undergo elective ICD implantation according to normal protocol. There will
      be no change in their treatment. After induction of general anaesthesia, an array of small
      self-adhesive electrodes (similar to ECG 'dots') will be placed on the patient's chest wall,
      and connected to a multichannel recording device.

      After implantation of the ICD, the device will be tested as per normal protocol. VF is
      induced in the patient. The ICD senses this arrhythmia, charges and immediately delivers a
      shock to the myocardium. As this shock is delivered, the investigators will record the
      current reaching the surface electrode array using the multichannel recorder. Most patients
      only require one shock as defibrillation rates with ICDs are >90%. If a second shock is
      required, the ICD will charge automatically and discharge once again. If this occurs, the
      investigators will also measure the cutaneous current at this second, higher energy level.
      The study is then concluded. Any subsequent shocks are delivered through external paddles and
      the investigators would not require any data from this stage of the procedure.

      STUDY POPULATION Number of Participants The investigators aim to assess 20 patients
      undergoing conventional ICD implantation and a further 20 patients undergoing S-ICD
      implantation.
observational model: Cohort
time perspective: Prospective
measure: Surface current during defibrillation
time frame: Approximately 10 mSec as the ICD discharges (i.e. at the time of testing)
description: To measure cutaneous leakage current on the chest wall during conventional and S-ICD discharge.
arm group label: Transvenous ICD
description: Patients with a transvenous ICD undergoing defibrillation testing.
arm group label: Subcutaneous ICD
description: Patients with a subcutaneous ICD undergoing defibrillation testing.
intervention type: Other
intervention name: Surface current measurement
description: Measurement of surface current between electrodes placed on the chest wall during defibrillation
arm group label: Subcutaneous ICD
arm group label: Transvenous ICD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Charles Deakin, MD
role: Principal Investigator
affiliation: University Hospital Southampton NHS Foundation Trust
facility: 
country: United Kingdom
citation: Willcox ME, Prutkin JM, Bardy GH. Recent developments in the subcutaneous ICD. Trends Cardiovasc Med. 2016 Aug;26(6):526-35. doi: 10.1016/j.tcm.2016.03.004. Epub 2016 Mar 15.
PMID: 27079889
citation: Chue CD, Kwok CS, Wong CW, Patwala A, Barker D, Zaidi A, Mamas MA, Cunnington C, Ahmed FZ. Efficacy and safety of the subcutaneous implantable cardioverter defibrillator: a systematic review. Heart. 2017 Sep;103(17):1315-1322. doi: 10.1136/heartjnl-2016-310852. Epub 2017 Jul 7.
PMID: 28687562
citation: Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.
PMID: 26477420
citation: Clements PA. Hazards of performing chest compressions in collapsed patients with internal cardioverter defibrillators. Emerg Med J. 2003 Jul;20(4):379-80. doi: 10.1136/emj.20.4.379. No abstract available.
PMID: 12835365
citation: Stockwell B, Bellis G, Morton G, Chung K, Merton WL, Andrews N, Smith GB. Electrical injury during "hands on" defibrillation-A potential risk of internal cardioverter defibrillators? Resuscitation. 2009 Jul;80(7):832-4. doi: 10.1016/j.resuscitation.2009.04.010. Epub 2009 May 14.
PMID: 19446388
citation: Niwano S, Kojima J, Inuo K, Saito J, Kashiwa T, Suyama M, Toyoshima T, Aizawa Y, Izumi T. Measurement of body surface energy leakage of defibrillation shock by an implantable cardioverter defibrillator. Pacing Clin Electrophysiol. 2002 Aug;25(8):1212-8. doi: 10.1046/j.1460-9592.2002.01212.x.
PMID: 12358172
responsible party type: Sponsor
mesh term: Heart Arrest
sharing ipd: Undecided
ipd description: Please contact researchers directly