<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/NCT02248753</url>
  </required_header>
  <id_info>
    <org_study_id>NL47065.068.13</org_study_id>
    <secondary_id>837002524</secondary_id>
    <nct_id>NCT02248753</nct_id>
  </id_info>
  <brief_title>Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department</brief_title>
  <acronym>RACE 7 ACWAS</acronym>
  <official_title>Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (RACE 7 ACWAS-trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A symptomatic episode of the heart rhythm disorder 'atrial fibrillation' (AF) is a frequent&#xD;
      reason for visits to the emergency department. Currently, in the majority of cases, immediate&#xD;
      (electrical or pharmacological) cardioversion is chosen, while atrial fibrillation terminates&#xD;
      spontaneously in 70% of the cases within 24 hours. A wait-and-see approach with rate-control&#xD;
      medication only, and when needed cardioversion within 48 hours of onset of symptoms, could be&#xD;
      effective, safe and more cost-effective than current standard of care and could lead to a&#xD;
      higher quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">November 2018</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>12-lead ECG</measure>
    <time_frame>4 weeks</time_frame>
    <description>Presence of sinus rhythm on ECG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to conversion to sinus rhythm (Holter monitor)</measure>
    <time_frame>48 hours</time_frame>
    <description>Intervention group only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF-36)</measure>
    <time_frame>Baseline, 4 weeks, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first recurrence of Atrial Fibrillation</measure>
    <time_frame>1 month</time_frame>
    <description>Monitoring through handheld device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total health care and societal costs</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (AFEQT)</measure>
    <time_frame>Baseline, 4 weeks, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">437</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pharmacological cardioversion and/or electrical cardioversion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-and-see Approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rate control drugs only (metoprolol, verapamil or digoxin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pharmacological cardioversion - Flecainide</intervention_name>
    <arm_group_label>Standard Care</arm_group_label>
    <other_name>Flecainide</other_name>
    <other_name>Tambocor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrical cardioversion</intervention_name>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metoprolol</intervention_name>
    <arm_group_label>Wait-and-see Approach</arm_group_label>
    <other_name>Selokeen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Verapamil</intervention_name>
    <arm_group_label>Wait-and-see Approach</arm_group_label>
    <other_name>Isoptin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Digoxin</intervention_name>
    <arm_group_label>Wait-and-see Approach</arm_group_label>
    <other_name>Lanoxin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pharmacological cardioversion - Amiodarone</intervention_name>
    <arm_group_label>Standard Care</arm_group_label>
    <other_name>Amiodarone</other_name>
    <other_name>Cordarone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ECG with atrial fibrillation at the emergency department&#xD;
&#xD;
          -  Heart rate &gt; 70bpm&#xD;
&#xD;
          -  Symptoms most probable due to atrial fibrillation&#xD;
&#xD;
          -  Duration of symptoms &lt; 36 hours&#xD;
&#xD;
          -  &gt; 18 years of age&#xD;
&#xD;
          -  Able and willing to sign informed consent&#xD;
&#xD;
          -  Able and willing to use MyDiagnostick&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Signs of myocardial infarction on ECG&#xD;
&#xD;
          -  Hemodynamic instability (systolic blood pressure &lt; 100mm Hg, heart rate &gt; 170 bpm)&#xD;
&#xD;
          -  Presence of pre-excitation syndrome&#xD;
&#xD;
          -  History of Sick Sinus Syndrome&#xD;
&#xD;
          -  History of unexplained syncope&#xD;
&#xD;
          -  History of persistent AF (episode of AF lasting more than 48 hours)&#xD;
&#xD;
          -  Acute heart failure&#xD;
&#xD;
          -  Currently enrolled in another clinical trial&#xD;
&#xD;
          -  Deemed unsuitable for participation by attending physician&#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>Harry J Crijns, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VU University Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Hospital</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Spectrum Twente</name>
      <address>
        <city>Enschede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zuyderland Medical Center</name>
      <address>
        <city>Heerlen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alrijne Hospital</name>
      <address>
        <city>Leiderdorp</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Hospital</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscus Gasthuis</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antonius Ziekenhuis</name>
      <address>
        <city>Sneek</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HagaZiekenhuis</name>
      <address>
        <city>The Hague</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elisabeth - TweeSteden Hospital</name>
      <address>
        <city>Tilburg</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diakonessenhuis</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VieCuri Medical Center</name>
      <address>
        <city>Venlo</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Dudink E, Essers B, Holvoet W, Weijs B, Luermans J, Ramanna H, Liem A, van Opstal J, Dekker L, van Dijk V, Lenderink T, Kamp O, Kulker L, Rienstra M, Kietselaer B, Alings M, Widdershoven J, Meeder J, Prins M, van Gelder I, Crijns H. Acute cardioversion vs a wait-and-see approach for recent-onset symptomatic atrial fibrillation in the emergency department: Rationale and design of the randomized ACWAS trial. Am Heart J. 2017 Jan;183:49-53. doi: 10.1016/j.ahj.2016.09.009. Epub 2016 Oct 2.</citation>
    <PMID>27979041</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Electrical cardioversion</keyword>
  <keyword>Pharmacological cardioversion</keyword>
  <keyword>Rhythm control</keyword>
  <keyword>Rate control</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>Metoprolol</mesh_term>
    <mesh_term>Digoxin</mesh_term>
    <mesh_term>Amiodarone</mesh_term>
    <mesh_term>Verapamil</mesh_term>
    <mesh_term>Flecainide</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/NCT02248753
org study id: NL47065.068.13
secondary id: 837002524
nct id: NCT02248753
lead sponsor: 
collaborator: 
has dmc: Yes
A symptomatic episode of the heart rhythm disorder 'atrial fibrillation' (AF) is a frequent
      reason for visits to the emergency department. Currently, in the majority of cases, immediate
      (electrical or pharmacological) cardioversion is chosen, while atrial fibrillation terminates
      spontaneously in 70% of the cases within 24 hours. A wait-and-see approach with rate-control
      medication only, and when needed cardioversion within 48 hours of onset of symptoms, could be
      effective, safe and more cost-effective than current standard of care and could lead to a
      higher quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 12-lead ECG
time frame: 4 weeks
description: Presence of sinus rhythm on ECG
measure: Time to conversion to sinus rhythm (Holter monitor)
time frame: 48 hours
description: Intervention group only
measure: Quality of life (SF-36)
time frame: Baseline, 4 weeks, 6 months, 12 months
measure: One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events
time frame: One year
measure: Time to first recurrence of Atrial Fibrillation
time frame: 1 month
description: Monitoring through handheld device
measure: Total health care and societal costs
time frame: 1 year
measure: Quality of Life (AFEQT)
time frame: Baseline, 4 weeks, 6 months, 12 months
arm group label: Standard Care
arm group type: Active Comparator
description: Pharmacological cardioversion and/or electrical cardioversion
arm group label: Wait-and-see Approach
arm group type: Experimental
description: Rate control drugs only (metoprolol, verapamil or digoxin)
intervention type: Drug
intervention name: Pharmacological cardioversion - Flecainide
arm group label: Standard Care
other name: Flecainide
other name: Tambocor
intervention type: Procedure
intervention name: Electrical cardioversion
arm group label: Standard Care
intervention type: Drug
intervention name: Metoprolol
arm group label: Wait-and-see Approach
other name: Selokeen
intervention type: Drug
intervention name: Verapamil
arm group label: Wait-and-see Approach
other name: Isoptin
intervention type: Drug
intervention name: Digoxin
arm group label: Wait-and-see Approach
other name: Lanoxin
intervention type: Drug
intervention name: Pharmacological cardioversion - Amiodarone
arm group label: Standard Care
other name: Amiodarone
other name: Cordarone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harry J Crijns, MD, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
citation: Dudink E, Essers B, Holvoet W, Weijs B, Luermans J, Ramanna H, Liem A, van Opstal J, Dekker L, van Dijk V, Lenderink T, Kamp O, Kulker L, Rienstra M, Kietselaer B, Alings M, Widdershoven J, Meeder J, Prins M, van Gelder I, Crijns H. Acute cardioversion vs a wait-and-see approach for recent-onset symptomatic atrial fibrillation in the emergency department: Rationale and design of the randomized ACWAS trial. Am Heart J. 2017 Jan;183:49-53. doi: 10.1016/j.ahj.2016.09.009. Epub 2016 Oct 2.
PMID: 27979041
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Emergencies
mesh term: Metoprolol
mesh term: Digoxin
mesh term: Amiodarone
mesh term: Verapamil
mesh term: Flecainide