<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/NCT04485195</url>
  </required_header>
  <id_info>
    <org_study_id>20200402</org_study_id>
    <nct_id>NCT04485195</nct_id>
  </id_info>
  <brief_title>RAFF4 Trial: Vernakalant vs. Procainamide for Acute Atrial Fibrillation in the Emergency Department</brief_title>
  <official_title>RAFF4 Trial: Vernakalant vs. Procainamide for Acute Atrial Fibrillation in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to compare IV vernakalant to IV procainamide for the ED management of acute&#xD;
      AF patients. If vernakalant proves to be more effective, faster, and safer than IV&#xD;
      procainamide, this will give clinicians an important alternative for pharmacological&#xD;
      cardioversion of acute AF. The investigators propose a pragmatic comparative effectiveness&#xD;
      trial entailing an open label, randomized controlled trial at 12 large Canadian EDs. Study&#xD;
      subjects will be randomized to 1 of 2 treatment arms: 1) Patients will receive an initial&#xD;
      infusion of 3mg/kg of IV vernakalant over 10 minutes, followed by a second dose of 2mg/kg&#xD;
      over 10 minutes, if necessary, or 2) Patients will receive a continuous infusion of 15mg/kg&#xD;
      of IV procainamide over 60 minutes. The primary aim will be to compare conversion to normal&#xD;
      sinus rhythm between the two drugs. The investigators will include stable patients presenting&#xD;
      with an episode of acute AF of at least 3 hours duration, where symptoms require urgent&#xD;
      management and where immediate cardioversion is a reasonable option. Using the integrated&#xD;
      consent model, research assistants will obtain verbal consent from eligible patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 17, 2021</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>Phase 4</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>Conversion to sinus rhythm for a minimum duration of 30 minutes</measure>
    <time_frame>During any time following randomization until 30 minutes past the completion of the drug infusion</time_frame>
    <description>Conversion to and maintenance of sinus rhythm for at least 30 minutes at any time following randomization until 30 minutes past the completion of the drug infusion. Heart rhythm will be determined by an electrocardiogram (ECG).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Normal sinus rhythm</measure>
    <time_frame>At the time of patient disposition (approximately 3 hours after arrival)</time_frame>
    <description>Being in normal sinus rhythm at the time of ED disposition (discharge or admission). Heart rhythm will be determined by an electrocardiogram (ECG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient disposition (admission or discharge)</measure>
    <time_frame>At the time of patient admission or discharge (approximately 3 hours after arrival)</time_frame>
    <description>Whether the patient was discharged home or admitted to the hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in ED</measure>
    <time_frame>From time of arrival until time of discharge or admission (approximately 3 hours)</time_frame>
    <description>Length of stay in ED in minutes, from time of arrival to time of discharge or admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to discharge</measure>
    <time_frame>From time of randomization until time of discharge or admission (approximately 3 hours)</time_frame>
    <description>Time to discharge in minutes, from time of randomization to time of discharge or admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to conversion</measure>
    <time_frame>From time of infusion start until time of conversion to sinus rhythm (approximately 0 - 90 minutes)</time_frame>
    <description>Time to conversion to sinus rhythm in minutes, from time of start of study drug infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whether the patient required electrical cardioversion</measure>
    <time_frame>From 30 minutes after the study drug infusion is completed.</time_frame>
    <description>Whether the patient required electrical cardioversion to restore normal sinus rhythm in the ED</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>0-12 hours</time_frame>
    <description>will be classified as serious or other, whether occurring 0-2 hours or 2-12 hours after infusion, whether infusion had to be halted or discontinued, or treatment required</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Maintenance of normal sinus rhythm</measure>
    <time_frame>30 days post discharge</time_frame>
    <description>Maintenance of normal sinus rhythm at 30 days after ED disposition, to be verified by hospital records, patient report, or by a smartphone application.</description>
  </other_outcome>
  <other_outcome>
    <measure>Recurrence of acute AF</measure>
    <time_frame>30 days</time_frame>
    <description>Recurrence of acute atrial fibrillation requiring an emergency department visit</description>
  </other_outcome>
  <other_outcome>
    <measure>Death</measure>
    <time_frame>30 days</time_frame>
    <description>within 30 days of ED disposition</description>
  </other_outcome>
  <other_outcome>
    <measure>Stroke</measure>
    <time_frame>30 days</time_frame>
    <description>transient ischemic attack, myocardial infarction, or other thromboembolic event within 30 days of ED disposition</description>
  </other_outcome>
  <other_outcome>
    <measure>Return to normal activities</measure>
    <time_frame>30 days</time_frame>
    <description>Return to normal daily activities measured in days</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">340</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Vernakalant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to this arm will receive an initial infusion of 3 mg/kg infused over a 10-minute period by a pre-programmed IV pump.82 For patients ≤ 100 kg the infusion is prepared by adding 25 mL of BRINAVESS 20 mg/mL to 100 mL of diluent creating a total volume of 125 mL at a concentration of 4 mg/mL. For patients &gt; 100 kg the infusion is prepared by adding 30 mL of BRINAVESS 20 mg/mL to 120 mL of diluent creating a total volume of 150 mL at a concentration of 4 mg/mL. For patients weighing ≥ 113 kg, the maximum initial dose is 339 mg (84.7 mL of 4 mg/mL solution).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Procainamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to this arm will receive a continuous infusion of IV procainamide with a dose of 15 mg/kg in 500 mL of normal saline given over 60 minutes (maximum dose 1,500 mg), by a pre-programmed pump. While the CAEP Best Practices Checklist suggests an infusion time of 30-60 minutes, we believe that a 60-minute period will avoid some adverse events.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vernakalant</intervention_name>
    <description>an initial infusion of 3 mg/kg infused over a 10-minute period by a pre-programmed IV pump</description>
    <arm_group_label>Vernakalant</arm_group_label>
    <other_name>BRINAVESS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Procainamide</intervention_name>
    <description>15 mg/kg in 500 mL of normal saline given over 60 minutes</description>
    <arm_group_label>Procainamide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The investigators will include stable (see below) patients presenting with an episode of&#xD;
        acute non-valvular AF of at least 3 hours duration and no greater than 7 days, where&#xD;
        symptoms require urgent management and where immediate cardioversion is a reasonable option&#xD;
        because:&#xD;
&#xD;
          1. The patient has been adequately anticoagulated for a minimum of 3 weeks (warfarin and&#xD;
             INR &gt; 2.0 or novel oral anticoagulants [dabigatran, rivaroxaban, edoxaban, and&#xD;
             apixaban]), or&#xD;
&#xD;
          2. The patient is not adequately anticoagulated for &gt; 3 weeks, has no history of stroke&#xD;
             or TIA, and does not have valvular heart disease, AND:&#xD;
&#xD;
        i) onset &lt; 12 hours ago, or ii) if onset 12 - 48 hours ago and there are &lt;2 of these&#xD;
        CHADS-65 criteria (age ≥ 65, diabetes, hypertension, heart failure), or iii) negative for&#xD;
        thrombus on transesophageal echocardiography. Of note, we will not exclude patients with&#xD;
        prior episodes of acute AF. Patients will only be enrolled if the attending physician is&#xD;
        confident about time of onset, based upon the patient's symptoms. Physicians are well aware&#xD;
        of the importance of this determination and will not attempt to cardiovert patients&#xD;
        otherwise.&#xD;
&#xD;
        Exclusion Criteria: The investigators will exclude patients who have any of the reasons&#xD;
        listed below.&#xD;
&#xD;
          1. Appropriateness:&#xD;
&#xD;
               1. unable to understand the study and integrated consent due to language barrier&#xD;
                  and/or cognitive impairment;&#xD;
&#xD;
               2. have permanent (chronic) AF;&#xD;
&#xD;
               3. have valvular heart disease (mitral stenosis, rheumatic or mechanical);&#xD;
&#xD;
               4. increased risk of stroke because onset not clearly &lt;48 hours and not&#xD;
                  anticoagulated (or abnormal TEE); or do not meet the inclusion criteria a or b;&#xD;
&#xD;
               5. deemed unstable and require immediate cardioversion: i) systolic blood pressure&#xD;
                  &lt;100 mmHg; ii) rapid ventricular preexcitation (Wolff-Parkinson-White syndrome);&#xD;
                  iii) acute coronary syndrome - chest pain and acute ischemic changes on ECG; or&#xD;
                  iv) pulmonary edema - severe dyspnea requiring immediate IV diuretic, nitrates,&#xD;
                  or BIPAP;&#xD;
&#xD;
               6. primary presentation was for another condition; examples include pneumonia,&#xD;
                  pulmonary embolism, and sepsis;&#xD;
&#xD;
               7. convert spontaneously to sinus rhythm prior to randomization;&#xD;
&#xD;
               8. were previously enrolled in the study; or&#xD;
&#xD;
               9. have atrial flutter.&#xD;
&#xD;
          2. Safety&#xD;
&#xD;
               1. has heart failure Class NYHA III or NYHA IV; left ventricular ejection fraction&#xD;
                  &lt;30%; or has clinical or radiological evidence of acute HF;&#xD;
&#xD;
               2. has presented with an acute coronary syndrome or acute decompensated heart&#xD;
                  failure, in the last 30 days; or has had a recent myocardial infarction (&lt; 3&#xD;
                  months);&#xD;
&#xD;
               3. has severe aortic stenosis;&#xD;
&#xD;
               4. has a systolic blood pressure &lt; 100 mmHg;&#xD;
&#xD;
               5. has a significantly prolonged QT interval at baseline e.g. uncorrected &gt; 440&#xD;
                  msec, congenital or acquired long QT syndrome; or a family history of Long QT&#xD;
                  syndrome; or ECG shows QTc &gt;460ms (when heart rate &gt;100 measured by the&#xD;
                  Fridericia formula);&#xD;
&#xD;
               6. has severe bradycardia (heart rate &lt; 55 bpm), sinus node dysfunction, or second&#xD;
                  or third degree atrioventricular heart block, in the absence of an in situ&#xD;
                  properly functioning pacemaker; or, has Brugada syndrome (genetic disease with&#xD;
                  increased risk of sudden cardiac death);&#xD;
&#xD;
               7. has received an intravenous antiarrhythmic drug Class I, e.g. procainamide, or&#xD;
                  Class Ill, e.g. amiodarone or ibutilide, within the prior 4 hours; or currently&#xD;
                  takes oral class I or III antiarrhythmic drugs other than amiodarone (last dose &lt;&#xD;
                  5 half-lives before enrollment);&#xD;
&#xD;
               8. has received an IV beta-blocker within the 2 hours prior&#xD;
&#xD;
               9. has hypersensitivity to the active substance or to any of the ingredients of&#xD;
                  either drug;&#xD;
&#xD;
              10. has advanced or end-stage liver disease; or&#xD;
&#xD;
              11. is breast feeding or pregnant (safety not established).&#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>Ian G Stiell, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ian G Stiell, MD, MSc</last_name>
    <phone>613-798-5555</phone>
    <phone_ext>18683</phone_ext>
    <email>istiell@ohri.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Erica Brown</last_name>
    <phone>613-798-5555</phone>
    <email>ericbrown@ohri.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Brian Rowe, MD</last_name>
      <phone>(780) 407-6707</phone>
      <email>Brian.Rowe@ualberta.ca</email>
    </contact>
    <investigator>
      <last_name>Brian Rowe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Corinne Hohl, MD</last_name>
      <email>chohl@mail.ubc.ca</email>
    </contact>
    <investigator>
      <last_name>Corinne Hohl, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Frank Scheuermeyer, MD</last_name>
      <email>frank.scheuermeyer@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samuel Campbell, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>l8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Michelle Welsford, MD</last_name>
      <phone>905521210044832</phone>
      <email>dr.m@welsford.ca</email>
    </contact>
    <contact_backup>
      <last_name>Natasha Clayton</last_name>
      <email>clayton@mcmaster.ca</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Kingston Health Sciences Centre</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K2L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marco Sivilotti, MD</last_name>
      <phone>6135496666</phone>
      <email>sivilott@queensu.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ian Stiell</last_name>
      <email>istiell@ohri.ca</email>
    </contact>
    <contact_backup>
      <last_name>Erica Brown</last_name>
      <email>ericbrown@ohri.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Ian Stiell, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Michaels</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Brian Steinhart, MD</last_name>
      <email>Brian.Steinhart@unityhealth.to</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ivy Cheng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval</name>
      <address>
        <city>Laval</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Pare, MD</last_name>
      <email>david.pare.med@ssss.gouv.qc.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Institute</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain Vadeboncoeur, MD</last_name>
      <email>alain.vadeboncoeur@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Alain Vadeboncoeur, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laurent Macle, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital Du Sacre-Coeur</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Judy Morris, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital de L'Enfant-Jesus</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric Mercier, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Marcel Emond, MD</last_name>
      <email>marcelemond1@me.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôtel-Dieu de Lévis</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Archambault, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Emergency Department</keyword>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Vernakalant</keyword>
  <keyword>Procainamide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Procainamide</mesh_term>
  </intervention_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/NCT04485195
org study id: 20200402
nct id: NCT04485195
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective is to compare IV vernakalant to IV procainamide for the ED management of acute
      AF patients. If vernakalant proves to be more effective, faster, and safer than IV
      procainamide, this will give clinicians an important alternative for pharmacological
      cardioversion of acute AF. The investigators propose a pragmatic comparative effectiveness
      trial entailing an open label, randomized controlled trial at 12 large Canadian EDs. Study
      subjects will be randomized to 1 of 2 treatment arms: 1) Patients will receive an initial
      infusion of 3mg/kg of IV vernakalant over 10 minutes, followed by a second dose of 2mg/kg
      over 10 minutes, if necessary, or 2) Patients will receive a continuous infusion of 15mg/kg
      of IV procainamide over 60 minutes. The primary aim will be to compare conversion to normal
      sinus rhythm between the two drugs. The investigators will include stable patients presenting
      with an episode of acute AF of at least 3 hours duration, where symptoms require urgent
      management and where immediate cardioversion is a reasonable option. Using the integrated
      consent model, research assistants will obtain verbal consent from eligible patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Conversion to sinus rhythm for a minimum duration of 30 minutes
time frame: During any time following randomization until 30 minutes past the completion of the drug infusion
description: Conversion to and maintenance of sinus rhythm for at least 30 minutes at any time following randomization until 30 minutes past the completion of the drug infusion. Heart rhythm will be determined by an electrocardiogram (ECG).
measure: Normal sinus rhythm
time frame: At the time of patient disposition (approximately 3 hours after arrival)
description: Being in normal sinus rhythm at the time of ED disposition (discharge or admission). Heart rhythm will be determined by an electrocardiogram (ECG).
measure: Patient disposition (admission or discharge)
time frame: At the time of patient admission or discharge (approximately 3 hours after arrival)
description: Whether the patient was discharged home or admitted to the hospital.
measure: Length of stay in ED
time frame: From time of arrival until time of discharge or admission (approximately 3 hours)
description: Length of stay in ED in minutes, from time of arrival to time of discharge or admission
measure: Time to discharge
time frame: From time of randomization until time of discharge or admission (approximately 3 hours)
description: Time to discharge in minutes, from time of randomization to time of discharge or admission
measure: Time to conversion
time frame: From time of infusion start until time of conversion to sinus rhythm (approximately 0 - 90 minutes)
description: Time to conversion to sinus rhythm in minutes, from time of start of study drug infusion
measure: Whether the patient required electrical cardioversion
time frame: From 30 minutes after the study drug infusion is completed.
description: Whether the patient required electrical cardioversion to restore normal sinus rhythm in the ED
measure: Adverse events
time frame: 0-12 hours
description: will be classified as serious or other, whether occurring 0-2 hours or 2-12 hours after infusion, whether infusion had to be halted or discontinued, or treatment required
measure: Maintenance of normal sinus rhythm
time frame: 30 days post discharge
description: Maintenance of normal sinus rhythm at 30 days after ED disposition, to be verified by hospital records, patient report, or by a smartphone application.
measure: Recurrence of acute AF
time frame: 30 days
description: Recurrence of acute atrial fibrillation requiring an emergency department visit
measure: Death
time frame: 30 days
description: within 30 days of ED disposition
measure: Stroke
time frame: 30 days
description: transient ischemic attack, myocardial infarction, or other thromboembolic event within 30 days of ED disposition
measure: Return to normal activities
time frame: 30 days
description: Return to normal daily activities measured in days
arm group label: Vernakalant
arm group type: Active Comparator
description: Patients randomized to this arm will receive an initial infusion of 3 mg/kg infused over a 10-minute period by a pre-programmed IV pump.82 For patients ≤ 100 kg the infusion is prepared by adding 25 mL of BRINAVESS 20 mg/mL to 100 mL of diluent creating a total volume of 125 mL at a concentration of 4 mg/mL. For patients > 100 kg the infusion is prepared by adding 30 mL of BRINAVESS 20 mg/mL to 120 mL of diluent creating a total volume of 150 mL at a concentration of 4 mg/mL. For patients weighing ≥ 113 kg, the maximum initial dose is 339 mg (84.7 mL of 4 mg/mL solution).
arm group label: Procainamide
arm group type: Active Comparator
description: Patients randomized to this arm will receive a continuous infusion of IV procainamide with a dose of 15 mg/kg in 500 mL of normal saline given over 60 minutes (maximum dose 1,500 mg), by a pre-programmed pump. While the CAEP Best Practices Checklist suggests an infusion time of 30-60 minutes, we believe that a 60-minute period will avoid some adverse events.
intervention type: Drug
intervention name: Vernakalant
description: an initial infusion of 3 mg/kg infused over a 10-minute period by a pre-programmed IV pump
arm group label: Vernakalant
other name: BRINAVESS
intervention type: Drug
intervention name: Procainamide
description: 15 mg/kg in 500 mL of normal saline given over 60 minutes
arm group label: Procainamide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ian G Stiell, MD, MSc
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
last name: Ian G Stiell, MD, MSc
phone: 613-798-5555
phone ext: 18683
email: istiell@ohri.ca
last name: Erica Brown
phone: 613-798-5555
email: ericbrown@ohri.ca
facility: 
status: Not yet recruiting
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country: Canada
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Emergencies
mesh term: Procainamide