<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/NCT02245009</url>
  </required_header>
  <id_info>
    <org_study_id>UKK-SEED-2014</org_study_id>
    <nct_id>NCT02245009</nct_id>
  </id_info>
  <brief_title>Safety of External Electrocardioversion in Device Patients</brief_title>
  <acronym>SEED</acronym>
  <official_title>Safety of External Electrocardioversion in Device Patients - the SEED Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Köln</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Köln</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Arrhythmias of the atria of the heart are a common comorbidity in patients with cardiac&#xD;
      rhythm management devices, such as pacemakers and implantable cardioverter/defibrillators&#xD;
      (ICD). External electrical cardioversion is an established method to achieve rhythm control&#xD;
      (restore normal sinus rhythm) in patients with atrial arrhythmia. Little data on safety and&#xD;
      efficacy of external electrical cardioversion in patients with cardiac rhythm management&#xD;
      devices exists. Thus, available data on the safety of external electrical cardioversion in&#xD;
      cardiac rhythm management patients lacks statistical power to accurately reflect the true&#xD;
      hazard of external electrical cardioversion in patients with cardiac rhythm management&#xD;
      devices.&#xD;
&#xD;
      The aim is to systematically include and follow all patients with cardiac rhythm management&#xD;
      devices presenting for external electrical cardioversion, to analyse the effects of external&#xD;
      electrical cardioversion on leads and devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Atrial arrhythmias are a common comorbidity in patients with cardiac rhythm&#xD;
      management (CRM) devices, such as pacemakers and ICD. External electrical cardioversion is an&#xD;
      established method to achieve rhythm control in patients with atrial arrhythmia. A paucity of&#xD;
      data on safety and efficacy of external electrical cardioversion in patients with cardiac&#xD;
      rhythm management devices exists. Most publications are of older date and predominantly case&#xD;
      reports or case collections. Few prospective studies with a population of cardiac rhythm&#xD;
      management patients after external electrical cardioversion have been published in recent&#xD;
      years.&#xD;
&#xD;
      Thus, available data on the safety of external electrical cardioversion in cardiac rhythm&#xD;
      management patients lacks statistical power to accurately reflect the true hazard of external&#xD;
      electrical cardioversion in patients with cardiac rhythm management devices.&#xD;
&#xD;
      Rationale Electrocardioversion in Propofol sedation for atrial or ventricular tachyarrhythmia&#xD;
      is an established therapy. It is routinely used for patients with cardiac rhythm management&#xD;
      devices and the risk of device and lead affectation is deemed to be low. This assumption is&#xD;
      currently not supported by substantial and current scientific data, mostly relying on older&#xD;
      reports. No large, prospective trials with a population of patients with modern cardiac&#xD;
      rhythm management devices exists.&#xD;
&#xD;
      Aim of the study The aim is to systematically include and follow all patients with cardiac&#xD;
      rhythm management devices presenting for external electrical cardioversion, to analyse the&#xD;
      effects of external electrical cardioversion on leads and devices. Thereby, providing&#xD;
      reliable evidence and detecting possible SAE with a low incidence. Furthermore, to gather&#xD;
      information on efficacy and recurrence rate in this population, to examine the value of&#xD;
      external electrical cardioversion for rhythm control in these patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>Composite safety endpoint: Changes of lead and device parameters</measure>
    <time_frame>2 weeks after CV</time_frame>
    <description>assessed by device interrogation, if any of the following criteria is met:&#xD;
a rise in threshold (at constant pulse duration) of &gt;1V&#xD;
exit block of any of the pacing leads&#xD;
loss of programming of the device&#xD;
rise in shock impedance by 50%&#xD;
rise in charge time by 50%&#xD;
drop in battery voltage of ≥0.2V within &lt; 6 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy Endpoint</measure>
    <time_frame>within 15 minutes after CV</time_frame>
    <description>Assessed by device interrogation and 12-lead ECG:&#xD;
- restoration of normal sinus rhythm after CV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late changes of lead parameters</measure>
    <time_frame>2 weeks after CV</time_frame>
    <description>Any of the below, assessed by device interrogation:&#xD;
Lead impedance &gt; 1000 Ohm&#xD;
a rise in lead impedance by 50%&#xD;
ventricular lead sensing &lt; 2mV&#xD;
atrial lead sensing &lt; 1mV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inadvertent induction of ventricular fibrillation</measure>
    <time_frame>10 seconds after CV</time_frame>
    <description>Assessed by 3 lead monitoring ECG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite endpoint: Early lead changes</measure>
    <time_frame>within 15 minutes after CV</time_frame>
    <description>assessed by device interrogation, if any of the following criteria is met:&#xD;
a rise in threshold (at constant pulse duration) of &gt;1V&#xD;
exit block of any of the pacing leads&#xD;
Lead impedance &gt; 1000 Ohm&#xD;
a rise in lead impedance by 50%&#xD;
ventricular lead sensing &lt; 2mV&#xD;
atrial lead sensing &lt; 1mV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loss of programming</measure>
    <time_frame>within 15 minutes after CV</time_frame>
    <description>assessed by device interrogation:&#xD;
- loss of programming of the device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of shock impedance</measure>
    <time_frame>within 15 minutes after CV</time_frame>
    <description>assessed by device interrogation:&#xD;
- rise in shock impedance by 50%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of charge time</measure>
    <time_frame>within 15 minutes after CV</time_frame>
    <description>assessed by device interrogation:&#xD;
- rise in charge time by 50%</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Atrial Arrhythmia</condition>
  <arm_group>
    <arm_group_label>Pacemaker patients</arm_group_label>
    <description>Patients with pacemaker, presenting for cardioversion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICD patients</arm_group_label>
    <description>Patients with ICD, presenting for cardioversion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CRT patients</arm_group_label>
    <description>Patients with CRT device, presenting for cardioversion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardioversion</intervention_name>
    <arm_group_label>CRT patients</arm_group_label>
    <arm_group_label>ICD patients</arm_group_label>
    <arm_group_label>Pacemaker patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with implanted cardiac rhythm devices (pacemakers, ICD and CRT)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Informed, written consent&#xD;
&#xD;
          -  Atrial or ventricular arrhythmia with indication for CV&#xD;
&#xD;
          -  Status post CRM implantation, including CRT-D&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Patients under guardianship or with mental disorders / disabilities&#xD;
&#xD;
          -  lead implantation &lt; 4 weeks prior to CV&#xD;
&#xD;
          -  contraindications for eCV or transoesophageal echocardiographie (TOE)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jakob Lüker, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Cologne</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Steven, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital Cologne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jakob Lüker, Dr.</last_name>
    <phone>+49221478</phone>
    <phone_ext>32396</phone_ext>
    <email>jakob.lueker@uk-koeln.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Cologne</name>
      <address>
        <city>Cologne</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Steven, Prof. Dr.</last_name>
      <phone>+49221478</phone>
      <phone_ext>32396</phone_ext>
      <email>daniel.steven@uk-koeln.de</email>
    </contact>
    <investigator>
      <last_name>Jakob Lüker, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>November 3, 2017</last_update_submitted>
  <last_update_submitted_qc>November 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02245009
org study id: UKK-SEED-2014
nct id: NCT02245009
lead sponsor: 
has dmc: Yes
Arrhythmias of the atria of the heart are a common comorbidity in patients with cardiac
      rhythm management devices, such as pacemakers and implantable cardioverter/defibrillators
      (ICD). External electrical cardioversion is an established method to achieve rhythm control
      (restore normal sinus rhythm) in patients with atrial arrhythmia. Little data on safety and
      efficacy of external electrical cardioversion in patients with cardiac rhythm management
      devices exists. Thus, available data on the safety of external electrical cardioversion in
      cardiac rhythm management patients lacks statistical power to accurately reflect the true
      hazard of external electrical cardioversion in patients with cardiac rhythm management
      devices.

      The aim is to systematically include and follow all patients with cardiac rhythm management
      devices presenting for external electrical cardioversion, to analyse the effects of external
      electrical cardioversion on leads and devices.
Introduction Atrial arrhythmias are a common comorbidity in patients with cardiac rhythm
      management (CRM) devices, such as pacemakers and ICD. External electrical cardioversion is an
      established method to achieve rhythm control in patients with atrial arrhythmia. A paucity of
      data on safety and efficacy of external electrical cardioversion in patients with cardiac
      rhythm management devices exists. Most publications are of older date and predominantly case
      reports or case collections. Few prospective studies with a population of cardiac rhythm
      management patients after external electrical cardioversion have been published in recent
      years.

      Thus, available data on the safety of external electrical cardioversion in cardiac rhythm
      management patients lacks statistical power to accurately reflect the true hazard of external
      electrical cardioversion in patients with cardiac rhythm management devices.

      Rationale Electrocardioversion in Propofol sedation for atrial or ventricular tachyarrhythmia
      is an established therapy. It is routinely used for patients with cardiac rhythm management
      devices and the risk of device and lead affectation is deemed to be low. This assumption is
      currently not supported by substantial and current scientific data, mostly relying on older
      reports. No large, prospective trials with a population of patients with modern cardiac
      rhythm management devices exists.

      Aim of the study The aim is to systematically include and follow all patients with cardiac
      rhythm management devices presenting for external electrical cardioversion, to analyse the
      effects of external electrical cardioversion on leads and devices. Thereby, providing
      reliable evidence and detecting possible SAE with a low incidence. Furthermore, to gather
      information on efficacy and recurrence rate in this population, to examine the value of
      external electrical cardioversion for rhythm control in these patients.
observational model: Cohort
time perspective: Prospective
measure: Composite safety endpoint: Changes of lead and device parameters
time frame: 2 weeks after CV
description: assessed by device interrogation, if any of the following criteria is met:
a rise in threshold (at constant pulse duration) of >1V
exit block of any of the pacing leads
loss of programming of the device
rise in shock impedance by 50%
rise in charge time by 50%
drop in battery voltage of ≥0.2V within < 6 weeks
measure: Efficacy Endpoint
time frame: within 15 minutes after CV
description: Assessed by device interrogation and 12-lead ECG:
- restoration of normal sinus rhythm after CV
measure: Late changes of lead parameters
time frame: 2 weeks after CV
description: Any of the below, assessed by device interrogation:
Lead impedance > 1000 Ohm
a rise in lead impedance by 50%
ventricular lead sensing < 2mV
atrial lead sensing < 1mV
measure: Inadvertent induction of ventricular fibrillation
time frame: 10 seconds after CV
description: Assessed by 3 lead monitoring ECG
measure: Composite endpoint: Early lead changes
time frame: within 15 minutes after CV
description: assessed by device interrogation, if any of the following criteria is met:
a rise in threshold (at constant pulse duration) of >1V
exit block of any of the pacing leads
Lead impedance > 1000 Ohm
a rise in lead impedance by 50%
ventricular lead sensing < 2mV
atrial lead sensing < 1mV
measure: Loss of programming
time frame: within 15 minutes after CV
description: assessed by device interrogation:
- loss of programming of the device
measure: Change of shock impedance
time frame: within 15 minutes after CV
description: assessed by device interrogation:
- rise in shock impedance by 50%
measure: Change of charge time
time frame: within 15 minutes after CV
description: assessed by device interrogation:
- rise in charge time by 50%
arm group label: Pacemaker patients
description: Patients with pacemaker, presenting for cardioversion.
arm group label: ICD patients
description: Patients with ICD, presenting for cardioversion.
arm group label: CRT patients
description: Patients with CRT device, presenting for cardioversion.
intervention type: Procedure
intervention name: Cardioversion
arm group label: CRT patients
arm group label: ICD patients
arm group label: Pacemaker patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jakob Lüker, Dr.
role: Principal Investigator
affiliation: University Hospital Cologne
last name: Daniel Steven, Prof. Dr.
role: Study Director
affiliation: University Hospital Cologne
last name: Jakob Lüker, Dr.
phone: +49221478
phone ext: 32396
email: jakob.lueker@uk-koeln.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac