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

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ClinicalTrials.gov Identifier: NCT02248753
Recruitment Status : Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE September 16, 2014
First Posted Date  ICMJE September 25, 2014
Last Update Posted Date January 11, 2019
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
12-lead ECG [ Time Frame: 4 weeks ]
Presence of sinus rhythm on ECG
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02248753 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
  • Time to conversion to sinus rhythm (Holter monitor) [ Time Frame: 48 hours ]
    Intervention group only
  • Quality of life (SF-36) [ Time Frame: Baseline, 4 weeks, 6 months, 12 months ]
  • One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events [ Time Frame: One year ]
  • Time to first recurrence of Atrial Fibrillation [ Time Frame: 1 month ]
    Monitoring through handheld device
  • Total health care and societal costs [ Time Frame: 1 year ]
  • Quality of Life (AFEQT) [ Time Frame: Baseline, 4 weeks, 6 months, 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department
Official Title  ICMJE Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (RACE 7 ACWAS-trial)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Pharmacological cardioversion - Flecainide
    Other Names:
    • Flecainide
    • Tambocor
  • Procedure: Electrical cardioversion
  • Drug: Metoprolol
    Other Name: Selokeen
  • Drug: Verapamil
    Other Name: Isoptin
  • Drug: Digoxin
    Other Name: Lanoxin
  • Drug: Pharmacological cardioversion - Amiodarone
    Other Names:
    • Amiodarone
    • Cordarone
Study Arms  ICMJE
  • Active Comparator: Standard Care
    Pharmacological cardioversion and/or electrical cardioversion
    Interventions:
    • Drug: Pharmacological cardioversion - Flecainide
    • Procedure: Electrical cardioversion
    • Drug: Pharmacological cardioversion - Amiodarone
  • Experimental: Wait-and-see Approach
    Rate control drugs only (metoprolol, verapamil or digoxin)
    Interventions:
    • Drug: Metoprolol
    • Drug: Verapamil
    • Drug: Digoxin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 22, 2014)
437
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02248753
Other Study ID Numbers  ICMJE NL47065.068.13
837002524 ( Other Grant/Funding Number: ZonMw )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE ZonMw: The Netherlands Organisation for Health Research and Development
Investigators  ICMJE
Principal Investigator: Harry J Crijns, MD, PhD Maastricht University Medical Center
PRS Account Maastricht University Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP