<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/NCT03817372</url>
  </required_header>
  <id_info>
    <org_study_id>66051</org_study_id>
    <nct_id>NCT03817372</nct_id>
  </id_info>
  <brief_title>Electrode Positions in Cardioverting Atrial Fibrillation</brief_title>
  <acronym>EPIC</acronym>
  <official_title>Comparison of Anterior-Posterior Versus Anterior-Lateral Electrode Position in Cardioverting Atrial Fibrillation - A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regionshospitalet Viborg, Skive</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Randers Regional Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Regionshospitalet Horsens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</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>
      Atrial fibrillation is the most common heart rhythm disorder, and the incidence is rapidly&#xD;
      increasing. Cardioversion using an electrical shock (DC-cardioversion) is an important&#xD;
      treatment to reduce symptoms and improve patient's quality-of-life. The treatment is&#xD;
      performed by applying gel electrodes to the chest. Cardioversion is not always successful,&#xD;
      and it is unknown which electrode-position provides the optimal efficacy.&#xD;
&#xD;
      This study aims to compare two electrode positions, which are in clinical use:&#xD;
      Anterior-posterior (left front and left back) versus anterior-lateral (right front and left&#xD;
      side of the chest).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Actual">October 2, 2020</completion_date>
  <primary_completion_date type="Actual">October 2, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy: First shock success</measure>
    <time_frame>Immediately after first cardioversion attempt.</time_frame>
    <description>The primary endpoint will be first shock efficacy, i.e. the proportion of patients in sinus rhythm for at least one minute immediately after an initial shock of 100 J.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Successful cardioversion</measure>
    <time_frame>One minute after cardioversion</time_frame>
    <description>The secondary efficacy endpoint will be cardioversion success, i.e. the proportion of patients in sinus rhythm for at least one minute after end of protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Number of participants with arrhythmic events during and after cardioversion</measure>
    <time_frame>Within 2 hours after cardioversion (until discharge)</time_frame>
    <description>Secondary safety endpoints will be arrhythmia during and after cardioversion (asystole, transient bradycardia, ventricular arrhythmia, atrioventricular block, recurrence of atrial fibrillation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Number of participants with skin-discomfort, skin burns or itching</measure>
    <time_frame>Two hours after cardioversion (at discharge)</time_frame>
    <description>Patient-reported peri-procedural discomfort when asked at discharge.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">468</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Anterior-posterior electrode position</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The anterior electrode is placed in the left parasternal area (precordium). The posterior electrode is placed in the left lower-scapular region with the electrode edge left to the spinal column.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anterior-lateral electrode position</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The anterior electrode is placed in the right parasternal area below the clavicle. The lateral electrode is placed with the center of the electrode in the left mid-axillary line in level with the V6 electrocardiogram electrode.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anterior-posterior electrode position</intervention_name>
    <description>Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position</description>
    <arm_group_label>Anterior-posterior electrode position</arm_group_label>
    <other_name>LIFEPAK 20, Physio-Control/Stryker</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anterior-lateral electrode position</intervention_name>
    <description>Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position</description>
    <arm_group_label>Anterior-lateral electrode position</arm_group_label>
    <other_name>LIFEPAK 20, Physio-Control/Stryker</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Atrial fibrillation (documented on an ECG-12)&#xD;
&#xD;
          2. Able and willing to sign informed consent&#xD;
&#xD;
          3. Age ≥ 18 years&#xD;
&#xD;
          4. Anticoagulation according to guidelines (Patients with atrial fibrillation for &gt;48&#xD;
             hours will be required to have a documented weekly international normalized ratio&#xD;
             (INR) ≥2.0 (including within 48 hours of cardioversion) or treatment with non-vitamin&#xD;
             K oral anticoagulant for three weeks or longer. Alternatively, a transoesophageal&#xD;
             echocardiogram documenting the absence of intracardiac thrombi is accepted and&#xD;
             cardioversion can be performed on treatment with low molecular weight heparin).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Implanted pacemaker and/or cardioverter defibrillator (ICD)&#xD;
&#xD;
          2. Prior enrollment in the trial&#xD;
&#xD;
          3. Hemodynamically unstable atrial fibrillation&#xD;
&#xD;
          4. Untreated hyperthyroidism&#xD;
&#xD;
          5. Known or suspected pregnancy&#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>Anders S Schmidt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Randers Regional Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Consultant cardiologist Andi E Albertsen, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Viborg Regional Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Professor Bo Løfgren, MD, PhD, FESC, FAHA</last_name>
    <role>Study Chair</role>
    <affiliation>University of Aarhus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Horsens Regional Hospital</name>
      <address>
        <city>Horsens</city>
        <zip>8700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Randers Regional Hospital</name>
      <address>
        <city>Randers</city>
        <zip>8930</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viborg Regional Hospital</name>
      <address>
        <city>Viborg</city>
        <zip>8800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardioversion</keyword>
  <keyword>Electrode position</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</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/NCT03817372
org study id: 66051
nct id: NCT03817372
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Atrial fibrillation is the most common heart rhythm disorder, and the incidence is rapidly
      increasing. Cardioversion using an electrical shock (DC-cardioversion) is an important
      treatment to reduce symptoms and improve patient's quality-of-life. The treatment is
      performed by applying gel electrodes to the chest. Cardioversion is not always successful,
      and it is unknown which electrode-position provides the optimal efficacy.

      This study aims to compare two electrode positions, which are in clinical use:
      Anterior-posterior (left front and left back) versus anterior-lateral (right front and left
      side of the chest).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy: First shock success
time frame: Immediately after first cardioversion attempt.
description: The primary endpoint will be first shock efficacy, i.e. the proportion of patients in sinus rhythm for at least one minute immediately after an initial shock of 100 J.
measure: Efficacy: Successful cardioversion
time frame: One minute after cardioversion
description: The secondary efficacy endpoint will be cardioversion success, i.e. the proportion of patients in sinus rhythm for at least one minute after end of protocol.
measure: Safety: Number of participants with arrhythmic events during and after cardioversion
time frame: Within 2 hours after cardioversion (until discharge)
description: Secondary safety endpoints will be arrhythmia during and after cardioversion (asystole, transient bradycardia, ventricular arrhythmia, atrioventricular block, recurrence of atrial fibrillation)
measure: Safety: Number of participants with skin-discomfort, skin burns or itching
time frame: Two hours after cardioversion (at discharge)
description: Patient-reported peri-procedural discomfort when asked at discharge.
arm group label: Anterior-posterior electrode position
arm group type: Active Comparator
description: The anterior electrode is placed in the left parasternal area (precordium). The posterior electrode is placed in the left lower-scapular region with the electrode edge left to the spinal column.
arm group label: Anterior-lateral electrode position
arm group type: Active Comparator
description: The anterior electrode is placed in the right parasternal area below the clavicle. The lateral electrode is placed with the center of the electrode in the left mid-axillary line in level with the V6 electrocardiogram electrode.
intervention type: Device
intervention name: Anterior-posterior electrode position
description: Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position
arm group label: Anterior-posterior electrode position
other name: LIFEPAK 20, Physio-Control/Stryker
intervention type: Device
intervention name: Anterior-lateral electrode position
description: Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position
arm group label: Anterior-lateral electrode position
other name: LIFEPAK 20, Physio-Control/Stryker
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anders S Schmidt, MD
role: Principal Investigator
affiliation: Randers Regional Hospital
last name: Consultant cardiologist Andi E Albertsen, MD, PhD
role: Study Director
affiliation: Viborg Regional Hospital
last name: Professor Bo Løfgren, MD, PhD, FESC, FAHA
role: Study Chair
affiliation: University of Aarhus
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Atrial Fibrillation