title: 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.
abstract: BACKGROUND
  Current standard of care for patients with recent-onset atrial fibrillation (AF) in the emergency department aims at urgent restoration of sinus rhythm, although paroxysmal AF is a condition that resolves spontaneously within 24 hours in more than 70% of the cases. A wait-and-see approach with rate-control medication only and when needed cardioversion within 48 hours of onset of symptoms is hypothesized to be noninferior, safe, and cost-effective as compared with current standard of care and to lead to a higher quality of life.
  
  
  METHODS
  The ACWAS trial (NCT02248753) is an investigator-initiated, randomized, controlled, 2-arm noninferiority trial that compares a wait-and-see approach to the standard of care. Consenting adults with recent-onset symptomatic AF in the emergency department without urgent need for cardioversion are eligible for participation. A total of 437 patients will be randomized to either standard care (pharmacologic or electrical cardioversion) or the wait-and-see approach, consisting of symptom reduction through rate control medication until spontaneous conversion is achieved, with the possibility of cardioversion within 48 hours after onset of symptoms. Primary end point is the presence of sinus rhythm on 12-lead electrocardiogram at 4 weeks; main secondary outcomes are adverse events, total medical and societal costs, quality of life, and cost-effectiveness for 1 year.
  
  
  CONCLUSIONS
  The ACWAS trial aims at providing evidence for the use of a wait-and-see approach for patients with recent-onset symptomatic AF in the emergency department.
authors.affiliation: Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht, Maastricht, the Netherlands.
authors.forename: Elton
authors.initials: E
authors.lastname: Dudink
authors.affiliation: Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Essers
authors.affiliation: Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht, Maastricht, the Netherlands; Department of Cardiology, VieCuri Medical Center, Venlo, the Netherlands.
authors.forename: Wouter
authors.initials: W
authors.lastname: Holvoet
authors.affiliation: Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht, Maastricht, the Netherlands; Department of Cardiology, VieCuri Medical Center, Venlo, the Netherlands.
authors.forename: Bob
authors.initials: B
authors.lastname: Weijs
authors.affiliation: Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht, Maastricht, the Netherlands.
authors.forename: Justin
authors.initials: J
authors.lastname: Luermans
authors.affiliation: Department of Cardiology, Haga Teaching Hospital, The Hague, the Netherlands.
authors.forename: Hemanth
authors.initials: H
authors.lastname: Ramanna
authors.affiliation: Department of Cardiology, Sint Franciscus Hospital, Rotterdam, the Netherlands.
authors.forename: Anho
authors.initials: A
authors.lastname: Liem
authors.affiliation: Department of Cardiology, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: Jurren
authors.initials: J
authors.lastname: van Opstal
authors.affiliation: Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
authors.forename: Lukas
authors.initials: L
authors.lastname: Dekker
authors.affiliation: Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands.
authors.forename: Vincent
authors.initials: V
authors.lastname: van Dijk
authors.affiliation: Department of Cardiology, Zuyderland Medical Center, Heerlen, the Netherlands.
authors.forename: Timo
authors.initials: T
authors.lastname: Lenderink
authors.affiliation: Department of Cardiology, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: Otto
authors.initials: O
authors.lastname: Kamp
authors.affiliation: Department of Cardiology, Alrijne Hospital, Leiderdorp, the Netherlands.
authors.forename: Lennert
authors.initials: L
authors.lastname: Kulker
authors.affiliation: Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Michiel
authors.initials: M
authors.lastname: Rienstra
authors.affiliation: Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht, Maastricht, the Netherlands.
authors.forename: Bas
authors.initials: B
authors.lastname: Kietselaer
authors.affiliation: Department of Cardiology, Amphia Hospital, Breda, the Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: Alings
authors.affiliation: Department of Cardiology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.
authors.forename: Jos
authors.initials: J
authors.lastname: Widdershoven
authors.affiliation: Department of Cardiology, VieCuri Medical Center, Venlo, the Netherlands.
authors.forename: Joan
authors.initials: J
authors.lastname: Meeder
authors.affiliation: Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands.
authors.forename: Martin
authors.initials: M
authors.lastname: Prins
authors.affiliation: Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Isabelle
authors.initials: I
authors.lastname: van Gelder
authors.affiliation: Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht, Maastricht, the Netherlands. Electronic address: hjgm.crijns@mumc.nl.
authors.forename: Harry
authors.initials: H
authors.lastname: Crijns
mesh_terms: D000328:Adult; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D000925:Anticoagulants / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy / Q000628:therapy*; D004554:Electric Countershock; D004562:Electrocardiography; D004636:Emergency Service, Hospital; D005260:Female; D005424:Flecainide / Q000627:therapeutic use*; D006339:Heart Rate; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008790:Metoprolol / Q000627:therapeutic use; D057832:Watchful Waiting
chemical_list: D000889:Anti-Arrhythmia Agents; D000925:Anticoagulants; D008790:Metoprolol; D005424:Flecainide