Comparison between acute restoration of normal sinus rhythm and a wait-and-see-approach until spontaneous restoration of normal sinus rhythm in patients with acute symptomatic atrial fibrillation (ACWAS-trial).

Rationale: Current guidelines recommend immediate cardioversion for patients with atrial fibrillation in the emergency department, 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.



Objective: Effectiveness (sinus rhythm), safety, and cost-effectiveness of a wait-and-see approach (WASA), consisting of symptom reduction through medication until spontaneous conversion is achieved, versus standard of care (acute cardioversion) for patients with symptomatic recent onset atrial fibrillation (AF) presenting at the emergency department (ED).



Study design: Randomized controlled non-inferiority trial in which a wait-and-see approach is compared directly to the standard of care. Total follow-up time is 1 year.



Study population: Patients with recent onset symptomatic AF at ED, age >18 years, suitable for both acute cardioversion and the wait-and-see approach.



Intervention: Wait-and-see approach (WASA), i.e. reduction of symptoms through adequate medication until spontaneous conversion to sinus rhythm, with delayed cardioversion if necessary.



Main study parameters/endpoints: Primary: presence of sinus rhythm on ECG at 4 weeks. Secondary: total costs, adverse events, and quality of life during 1 year.

A Wait and See-approach is non-inferior on percentage of patients in sinus rhythm at 1 month as compared to acute cardioversion, but leads to a higher quality of life and less costs.

In intervention group only: Visit to outpatient clinic within 48 hours after index visit



All patients:

Visit at 1 month (questionnaires, ECG: primary outcome). Questionnaires at 6 and 12 months.

A wait and see-approach, consisting of rate control drugs. Within 48 hours, patients will report to the outpatient clinic to check for spontaneous conversion to sinus rhythm.