<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/NCT02192957</url>
  </required_header>
  <id_info>
    <org_study_id>20140415</org_study_id>
    <secondary_id>Form ID 2788</secondary_id>
    <nct_id>NCT02192957</nct_id>
  </id_info>
  <brief_title>The Ottawa AF Cardioversion Protocol</brief_title>
  <official_title>Developing a Standardized Atrial Fibrillation Cardioversion Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David Birnie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Heart Institute Research Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atrial fibrillation is an abnormal heart rhythm in which the top chambers of the heart (the&#xD;
      atrial chambers) beat very fast. Electrical cardioversion is a technique to convert heart&#xD;
      rhythm from AF to normal rhythm. The technique sends out a brief electric shock to the heart&#xD;
      through electrodes (paddles or skin patches) applied to the outside of the chest wall. The&#xD;
      shock resets the heart rhythm back to its normal pattern.&#xD;
&#xD;
      This technique is practiced at many hospitals, including the Heart Institute, and is not&#xD;
      experimental. However no detailed national or international guidelines exist to assist&#xD;
      physicians in performing cardioversion. Physicians use a variety of methods. Electrical&#xD;
      cardioversion does not always restore normal rhythm. Adjusting the electrical energy dose,&#xD;
      changing the electrode position and applying pressure to the electrodes may improve the&#xD;
      success rate.&#xD;
&#xD;
      This study will look at the safety and efficacy of a protocol (step by step method) for&#xD;
      electrical cardioversion. The protocol prescribes the electrical energy dose, the electrode&#xD;
      position and the application of pressure to the electrodes the physician will use. The&#xD;
      individual elements of the protocol (energy dose, electrode position and pressure&#xD;
      application) are often used by physician in clinical practice but not necessarily in the step&#xD;
      by step order.&#xD;
&#xD;
      The purpose of this study is to get all doctors to follow a standard protocol 'the Ottawa AF&#xD;
      cardioversion protocol'. We think that using this protocol will improve overall cardioversion&#xD;
      success rates. The results of this study may change usual practice in Canada and in other&#xD;
      countries.&#xD;
&#xD;
      All supplies, equipment and medications used in the protocol cardioversion are approved by&#xD;
      Health Canada.&#xD;
&#xD;
      We estimate that 389 participants from the University of Ottawa Heart Institute will be&#xD;
      enrolled in the study over the next 2 years. The results will be compared with a group of&#xD;
      previous patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design:&#xD;
&#xD;
      All eligible and consenting patients will undergo elective electrical cardioversion for&#xD;
      atrial fibrillation (AF) using the Ottawa AF protocol.The fact that the physician follows the&#xD;
      protocol makes this experimental. Aside from following the protocol, subjects will receive&#xD;
      standard care before, during and after the procedure. Outcomes of the procedure and clinical&#xD;
      features know to affect cardioversion efficacy will be collected. These will be compared to a&#xD;
      group of 500 previous patients who underwent elective electrical cardioversion for AF at the&#xD;
      Heart Institute.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      The Ottawa AF protocol prescribes the electrical energy dose, the electrode position and the&#xD;
      application of pressure to the electrodes the physician will use. The individual elements of&#xD;
      the protocol (energy dose, electrode position and pressure application) are often used by&#xD;
      physician in clinical practice but not necessarily in the step by step order.&#xD;
&#xD;
      The Ottawa AF protocol prescribes the following:&#xD;
&#xD;
        -  the starting energy dose (200 J) and electrode placement (anterior-posterior)&#xD;
&#xD;
        -  the second electrode placement (anterior-lateral) if the first shock is not successful&#xD;
&#xD;
        -  addition of pressure to electrodes if second shock is not successful&#xD;
&#xD;
        -  step up of energy dose (360 J) along with pressure to electrodes if third shock is not&#xD;
           successful&#xD;
&#xD;
        -  optional further steps at physician's choice if fourth shock is not successful&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Last shock efficacy</measure>
    <time_frame>immediately after cardioversion</time_frame>
    <description>Last shock efficacy defined as success ( two or more beats of sinus rhythm) or failure.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>participants will be followed for the duration of hospital stay for elective cardioversion, an expected average of 2 hours.</time_frame>
    <description>adverse events related to cardioversion</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">389</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Ottawa AF Cardioversion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>elective electrical cardioversion for atrial fibrillation (AF) using the Ottawa AF protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lifepak 20E Defibrillator, Licence No: 61944</intervention_name>
    <description>Intervention will be carried out using Health Canada approved devices for electrical cardioversion, following the steps pre-specified in the Ottawa AF Protocol.&#xD;
Ottawa AF Cardioversion</description>
    <arm_group_label>Ottawa AF Cardioversion</arm_group_label>
    <other_name>-HEARTSTART XL, Licence No: 24413.</other_name>
    <other_name>-Kendall 1010P Multi-function Defibrillation Electrodes, Licence No: 21857</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented atrial fibrillation within last 12 months&#xD;
&#xD;
          -  On continuous systemic oral anticoagulation for 28 days prior to the day of&#xD;
             cardioversion or must have undergone a recent (&lt; 48 hrs) trans-esophageal&#xD;
             echocardiogram prior to the day of cardioversion&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of intracardiac thrombus&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David H Birnie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Heart Institute Research Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Ottawa Heart Institution</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Ramirez FD, Sadek MM, Boileau I, Cleland M, Nery PB, Nair GM, Redpath CJ, Green MS, Davis DR, Charron K, Henne J, Zakutney T, Beanlands RSB, Hibbert B, Wells GA, Birnie DH. Evaluation of a novel cardioversion intervention for atrial fibrillation: the Ottawa AF cardioversion protocol. Europace. 2019 May 1;21(5):708-715. doi: 10.1093/europace/euy285.</citation>
    <PMID>30535367</PMID>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ottawa Heart Institute Research Corporation</investigator_affiliation>
    <investigator_full_name>David Birnie</investigator_full_name>
    <investigator_title>BSc (Hons), MB ChB, MRCP(UK), MD</investigator_title>
  </responsible_party>
  <keyword>cardioversion</keyword>
  <keyword>electrical cardioversion</keyword>
  <keyword>atrial fibrillation</keyword>
  <keyword>cardioversion protocol</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/NCT02192957
org study id: 20140415
secondary id: Form ID 2788
nct id: NCT02192957
lead sponsor: 
has dmc: No
Atrial fibrillation is an abnormal heart rhythm in which the top chambers of the heart (the
      atrial chambers) beat very fast. Electrical cardioversion is a technique to convert heart
      rhythm from AF to normal rhythm. The technique sends out a brief electric shock to the heart
      through electrodes (paddles or skin patches) applied to the outside of the chest wall. The
      shock resets the heart rhythm back to its normal pattern.

      This technique is practiced at many hospitals, including the Heart Institute, and is not
      experimental. However no detailed national or international guidelines exist to assist
      physicians in performing cardioversion. Physicians use a variety of methods. Electrical
      cardioversion does not always restore normal rhythm. Adjusting the electrical energy dose,
      changing the electrode position and applying pressure to the electrodes may improve the
      success rate.

      This study will look at the safety and efficacy of a protocol (step by step method) for
      electrical cardioversion. The protocol prescribes the electrical energy dose, the electrode
      position and the application of pressure to the electrodes the physician will use. The
      individual elements of the protocol (energy dose, electrode position and pressure
      application) are often used by physician in clinical practice but not necessarily in the step
      by step order.

      The purpose of this study is to get all doctors to follow a standard protocol 'the Ottawa AF
      cardioversion protocol'. We think that using this protocol will improve overall cardioversion
      success rates. The results of this study may change usual practice in Canada and in other
      countries.

      All supplies, equipment and medications used in the protocol cardioversion are approved by
      Health Canada.

      We estimate that 389 participants from the University of Ottawa Heart Institute will be
      enrolled in the study over the next 2 years. The results will be compared with a group of
      previous patients.
Study design:

      All eligible and consenting patients will undergo elective electrical cardioversion for
      atrial fibrillation (AF) using the Ottawa AF protocol.The fact that the physician follows the
      protocol makes this experimental. Aside from following the protocol, subjects will receive
      standard care before, during and after the procedure. Outcomes of the procedure and clinical
      features know to affect cardioversion efficacy will be collected. These will be compared to a
      group of 500 previous patients who underwent elective electrical cardioversion for AF at the
      Heart Institute.

      Methodology:

      The Ottawa AF protocol prescribes the electrical energy dose, the electrode position and the
      application of pressure to the electrodes the physician will use. The individual elements of
      the protocol (energy dose, electrode position and pressure application) are often used by
      physician in clinical practice but not necessarily in the step by step order.

      The Ottawa AF protocol prescribes the following:

        -  the starting energy dose (200 J) and electrode placement (anterior-posterior)

        -  the second electrode placement (anterior-lateral) if the first shock is not successful

        -  addition of pressure to electrodes if second shock is not successful

        -  step up of energy dose (360 J) along with pressure to electrodes if third shock is not
           successful

        -  optional further steps at physician's choice if fourth shock is not successful
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Last shock efficacy
time frame: immediately after cardioversion
description: Last shock efficacy defined as success ( two or more beats of sinus rhythm) or failure.
measure: Adverse Events
time frame: participants will be followed for the duration of hospital stay for elective cardioversion, an expected average of 2 hours.
description: adverse events related to cardioversion
arm group label: Ottawa AF Cardioversion
arm group type: Other
description: elective electrical cardioversion for atrial fibrillation (AF) using the Ottawa AF protocol
intervention type: Device
intervention name: Lifepak 20E Defibrillator, Licence No: 61944
description: Intervention will be carried out using Health Canada approved devices for electrical cardioversion, following the steps pre-specified in the Ottawa AF Protocol.
Ottawa AF Cardioversion
arm group label: Ottawa AF Cardioversion
other name: -HEARTSTART XL, Licence No: 24413.
other name: -Kendall 1010P Multi-function Defibrillation Electrodes, Licence No: 21857
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: David H Birnie, MD
role: Principal Investigator
affiliation: Ottawa Heart Institute Research Corporation
facility: 
country: Canada
citation: Ramirez FD, Sadek MM, Boileau I, Cleland M, Nery PB, Nair GM, Redpath CJ, Green MS, Davis DR, Charron K, Henne J, Zakutney T, Beanlands RSB, Hibbert B, Wells GA, Birnie DH. Evaluation of a novel cardioversion intervention for atrial fibrillation: the Ottawa AF cardioversion protocol. Europace. 2019 May 1;21(5):708-715. doi: 10.1093/europace/euy285.
PMID: 30535367
responsible party type: Sponsor-Investigator
investigator affiliation: Ottawa Heart Institute Research Corporation
investigator full name: David Birnie
investigator title: BSc (Hons), MB ChB, MRCP(UK), MD
mesh term: Atrial Fibrillation