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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
437
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
...and 5 more locations
12-lead ECG
Presence of sinus rhythm on ECG
Time frame: 4 weeks
Time to conversion to sinus rhythm (Holter monitor)
Intervention group only
Time frame: 48 hours
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
Monitoring through handheld device
Time frame: 1 month
Total health care and societal costs
Time frame: 1 year
Quality of Life (AFEQT)
Time frame: Baseline, 4 weeks, 6 months, 12 months
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