xml: <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/NCT05992623</url>
    </required_header>
    <id_info>
      <org_study_id>U23-04-5042</org_study_id>
      <nct_id>NCT05992623</nct_id>
    </id_info>
    <brief_title>Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation</brief_title>
    <official_title>A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs Lifepak)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inova Health Care Services</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Inova Health Care Services</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this single center, investigator initiated, open label prospective randomized&#xD;
        controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE&#xD;
        shock. The secondary objective of the study is to compare the frequency of adverse events&#xD;
        after one or two 200J RBW or 360J BTE shocks&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Data will be derived from approximately 560 patients arriving to Inova sites of care in&#xD;
        Atrial Fibrillation (AF) scheduled to undergo either Atrial Fibrillation ablation with&#xD;
        expected Direct Current Cardioversion (DCCV) or elective stand-alone AF DCCV. Patients will&#xD;
        be included if they are in AF prior to their procedure and are willing to sign the&#xD;
        information sheet and comply with the research procedures. Participants will be excluded if&#xD;
        they are in a rhythm other than AF on arrival, have not been appropriately anticoagulated&#xD;
        with warfarin or direct oral anticoagulant, or have known left atrial appendage thrombus&#xD;
        prior to their procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">July 21, 2023</start_date>
    <completion_date type="Anticipated">November 23, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 23, 2024</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Participants will be randomized to a Zoll or Lifepak defibrillator to perform the DCCV. All shocks will be full output (200J for Zoll shocks and 360J for Lifepak shocks). Follow up will be assessment and documentation of rhythm 1 minute after the last shock is delivered. Participants who do not have first shock success will have a second full output shock ≥1 minute after the first shock. Participants who do not have success after a second full output shock will be crossed over to the other defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The number of participants in normal sinus rhythm (NSR) by ECG after the first DCCV shock</measure>
      <time_frame>Up to 1 minute after shock delivered</time_frame>
      <description>The frequency of NSR one minute, identified by ECG, after a single full output DCCV shock is delivered by either a Zoll RBW waveform defibrillator or Lifepak BTE waveform defibrillator</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">560</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules) up to 2 shocks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Zoll defibrillator waveform used after unsuccessful second full output shock.</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants who received first shock via Zoll that do not have success after a second full output shock will be crossed over to the Lifepak defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Lifepak defibrillator waveform used after unsuccessful second full output shock.</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants who received first shock via Lifepak that do not have success after a second full output shock will be crossed over to the Zoll defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Zoll external defibrillator</intervention_name>
      <description>Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator</description>
      <arm_group_label>Lifepak defibrillator waveform used after unsuccessful second full output shock.</arm_group_label>
      <arm_group_label>Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Lifepak external defibrillator</intervention_name>
      <description>Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator</description>
      <arm_group_label>Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator</arm_group_label>
      <arm_group_label>Zoll defibrillator waveform used after unsuccessful second full output shock.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years&#xD;
  &#xD;
            2. In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV&#xD;
               procedure area&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants who are receiving any other investigational agents.&#xD;
  &#xD;
            2. Parents/guardians or participants who, in the opinion of the Investigator, may be&#xD;
               non-compliant with study schedules or procedures.&#xD;
  &#xD;
            3. Patients with arrhythmias other than AF&#xD;
  &#xD;
            4. Patients with hemodynamically unstable AF&#xD;
  &#xD;
            5. Patients with untreated hyperthyroidism&#xD;
  &#xD;
            6. Patients with known or suspected pregnancy&#xD;
  &#xD;
            7. Patients without sufficient anticoagulation or a transesophageal echocardiogram or&#xD;
               computed tomography scan documenting the absence of intracardiac thrombi&#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>Brett Atwater, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Inova Health Care Services</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Inova Health System</name>
        <address>
          <city>Falls Church</city>
          <state>Virginia</state>
          <zip>22042</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</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>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992623
  org study id: U23-04-5042
  nct id: NCT05992623
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The goal of this single center, investigator initiated, open label prospective randomized
        controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE
        shock. The secondary objective of the study is to compare the frequency of adverse events
        after one or two 200J RBW or 360J BTE shocks
  Data will be derived from approximately 560 patients arriving to Inova sites of care in
        Atrial Fibrillation (AF) scheduled to undergo either Atrial Fibrillation ablation with
        expected Direct Current Cardioversion (DCCV) or elective stand-alone AF DCCV. Patients will
        be included if they are in AF prior to their procedure and are willing to sign the
        information sheet and comply with the research procedures. Participants will be excluded if
        they are in a rhythm other than AF on arrival, have not been appropriately anticoagulated
        with warfarin or direct oral anticoagulant, or have known left atrial appendage thrombus
        prior to their procedure.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Participants will be randomized to a Zoll or Lifepak defibrillator to perform the DCCV. All shocks will be full output (200J for Zoll shocks and 360J for Lifepak shocks). Follow up will be assessment and documentation of rhythm 1 minute after the last shock is delivered. Participants who do not have first shock success will have a second full output shock ≥1 minute after the first shock. Participants who do not have success after a second full output shock will be crossed over to the other defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The number of participants in normal sinus rhythm (NSR) by ECG after the first DCCV shock
  time frame: Up to 1 minute after shock delivered
  description: The frequency of NSR one minute, identified by ECG, after a single full output DCCV shock is delivered by either a Zoll RBW waveform defibrillator or Lifepak BTE waveform defibrillator
  arm group label: Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator
  arm group type: Active Comparator
  description: Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks.
  arm group label: Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator
  arm group type: Active Comparator
  description: Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules) up to 2 shocks.
  arm group label: Zoll defibrillator waveform used after unsuccessful second full output shock.
  arm group type: Active Comparator
  description: Participants who received first shock via Zoll that do not have success after a second full output shock will be crossed over to the Lifepak defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock.
  arm group label: Lifepak defibrillator waveform used after unsuccessful second full output shock.
  arm group type: Active Comparator
  description: Participants who received first shock via Lifepak that do not have success after a second full output shock will be crossed over to the Zoll defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock.
  intervention type: Device
  intervention name: Zoll external defibrillator
  description: Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator
  arm group label: Lifepak defibrillator waveform used after unsuccessful second full output shock.
  arm group label: Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator
  intervention type: Device
  intervention name: Lifepak external defibrillator
  description: Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator
  arm group label: Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator
  arm group label: Zoll defibrillator waveform used after unsuccessful second full output shock.
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Brett Atwater, MD
  role: Principal Investigator
  affiliation: Inova Health Care Services
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation