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Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (RACE 7 ACWAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02248753
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Pharmacological cardioversion - Flecainide Procedure: Electrical cardioversion Drug: Metoprolol Drug: Verapamil Drug: Digoxin Drug: Pharmacological cardioversion - Amiodarone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 437 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (RACE 7 ACWAS-trial)
Actual Study Start Date : October 2014
Actual Primary Completion Date : November 2018
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Care
Pharmacological cardioversion and/or electrical cardioversion
Drug: Pharmacological cardioversion - Flecainide
Other Names:
  • Flecainide
  • Tambocor

Procedure: Electrical cardioversion
Drug: Pharmacological cardioversion - Amiodarone
Other Names:
  • Amiodarone
  • Cordarone

Experimental: Wait-and-see Approach
Rate control drugs only (metoprolol, verapamil or digoxin)
Drug: Metoprolol
Other Name: Selokeen

Drug: Verapamil
Other Name: Isoptin

Drug: Digoxin
Other Name: Lanoxin




Primary Outcome Measures :
  1. 12-lead ECG [ Time Frame: 4 weeks ]
    Presence of sinus rhythm on ECG


Secondary Outcome Measures :
  1. Time to conversion to sinus rhythm (Holter monitor) [ Time Frame: 48 hours ]
    Intervention group only

  2. Quality of life (SF-36) [ Time Frame: Baseline, 4 weeks, 6 months, 12 months ]
  3. One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events [ Time Frame: One year ]
  4. Time to first recurrence of Atrial Fibrillation [ Time Frame: 1 month ]
    Monitoring through handheld device

  5. Total health care and societal costs [ Time Frame: 1 year ]
  6. Quality of Life (AFEQT) [ Time Frame: Baseline, 4 weeks, 6 months, 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECG with atrial fibrillation at the emergency department
  • Heart rate > 70bpm
  • Symptoms most probable due to atrial fibrillation
  • Duration of symptoms < 36 hours
  • > 18 years of age
  • Able and willing to sign informed consent
  • Able and willing to use MyDiagnostick

Exclusion Criteria:

  • Signs of myocardial infarction on ECG
  • Hemodynamic instability (systolic blood pressure < 100mm Hg, heart rate > 170 bpm)
  • Presence of pre-excitation syndrome
  • History of Sick Sinus Syndrome
  • History of unexplained syncope
  • History of persistent AF (episode of AF lasting more than 48 hours)
  • Acute heart failure
  • Currently enrolled in another clinical trial
  • Deemed unsuitable for participation by attending physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248753


Locations
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Netherlands
VU University Medical Center
Amsterdam, Netherlands
Amphia Hospital
Breda, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Zuyderland Medical Center
Heerlen, Netherlands
Alrijne Hospital
Leiderdorp, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Franciscus Gasthuis
Rotterdam, Netherlands
Antonius Ziekenhuis
Sneek, Netherlands
HagaZiekenhuis
The Hague, Netherlands
St. Elisabeth - TweeSteden Hospital
Tilburg, Netherlands
Diakonessenhuis
Utrecht, Netherlands
VieCuri Medical Center
Venlo, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Harry J Crijns, MD, PhD Maastricht University Medical Center

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02248753    
Other Study ID Numbers: NL47065.068.13
837002524 ( Other Grant/Funding Number: ZonMw )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Keywords provided by Maastricht University Medical Center:
Atrial fibrillation
Electrical cardioversion
Pharmacological cardioversion
Rhythm control
Rate control
Additional relevant MeSH terms:
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Atrial Fibrillation
Emergencies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes
Metoprolol
Digoxin
Amiodarone
Verapamil
Flecainide
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Enzyme Inhibitors
Protective Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators