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

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02248753
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other)
437
Enrollment
15
Locations
2
Arms
62
Actual Duration (Months)
29.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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
N/A

Study Design

Study Type:
Interventional
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 :
Oct 1, 2014
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

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 Names:
  • Selokeen

    • Drug: Verapamil
    Other Names:
  • Isoptin

    • Drug: Digoxin
    Other Names:
  • Lanoxin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 12-lead ECG [4 weeks]

      Presence of sinus rhythm on ECG

    Secondary Outcome Measures

    1. Time to conversion to sinus rhythm (Holter monitor) [48 hours]

      Intervention group only

    2. Quality of life (SF-36) [Baseline, 4 weeks, 6 months, 12 months]

    3. One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events [One year]

    4. Time to first recurrence of Atrial Fibrillation [1 month]

      Monitoring through handheld device

    5. Total health care and societal costs [1 year]

    6. Quality of Life (AFEQT) [Baseline, 4 weeks, 6 months, 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VU University Medical Center Amsterdam Netherlands
    2 Amphia Hospital Breda Netherlands
    3 Catharina Ziekenhuis Eindhoven Netherlands
    4 Medisch Spectrum Twente Enschede Netherlands
    5 University Medical Center Groningen Groningen Netherlands
    6 Zuyderland Medical Center Heerlen Netherlands
    7 Alrijne Hospital Leiderdorp Netherlands
    8 Maastricht University Medical Center Maastricht Netherlands
    9 St. Antonius Hospital Nieuwegein Netherlands
    10 Franciscus Gasthuis Rotterdam Netherlands
    11 Antonius Ziekenhuis Sneek Netherlands
    12 HagaZiekenhuis The Hague Netherlands
    13 St. Elisabeth - TweeSteden Hospital Tilburg Netherlands
    14 Diakonessenhuis Utrecht Netherlands
    15 VieCuri Medical Center Venlo Netherlands

    Sponsors and Collaborators

    • Maastricht University Medical Center
    • ZonMw: The Netherlands Organisation for Health Research and Development

    Investigators

    • Principal Investigator: Harry J Crijns, MD, PhD, Maastricht University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02248753
    Other Study ID Numbers:
    • NL47065.068.13
    • 837002524
    First Posted:
    Sep 25, 2014
    Last Update Posted:
    Jan 21, 2020
    Last Verified:
    Jan 1, 2020
    Keywords provided by Maastricht University Medical Center
    Atrial fibrillation
    Electrical cardioversion
    Pharmacological cardioversion
    Rhythm control
    Rate control
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Emergencies
    Metoprolol
    Digoxin
    Amiodarone
    Verapamil
    Flecainide

    Study Results

    No Results Posted as of Jan 21, 2020