Device-based rate versus rhythm control treatment in patients with symptomatic recent-onset atrial fibrillation in the emergency department
Rationale: Until recently standard of care for patients with recent-onset atrial fibrillation (AF) was early cardioversion. This has just been expanded with a delayed cardioversion approach (Pluymakers et al New Engl J Med 2019)
Considering the recurrent and transient nature of AF, cardioversion might not be needed at all and rate control medication might be sufficient to accomplish spontaneous conversion to sinus rhythm.
Objective: To assess effectiveness (presence of sinus rhythm) and cost-effectiveness of a watchful-waiting approach, i.e. symptom reduction through medication until spontaneous conversion is achieved compared to a delayed cardioversion approach, i.e. rate control medication and delayed cardioversion if spontaneous conversion does not occur < 48 hours, for patients with recent-onset symptomatic paroxysmal AF.
Study design: a multicentre prospective, randomized, open label, non-inferiority trial comparing the interventional watchful-waiting approach to the delayed cardioversion approach (control).Total follow-up time is 1 year.
Study population: patients with recent-onset symptomatic paroxysmal AF (<36 hours) presenting at the ED, age >18 years, suitable for both intervention and control arm.
Intervention: watchful-waiting approach consisting of administration of rate control medication to obtain relief of symptoms and a heart rate <110 beats per minute, followed by a telemetric rhythm monitoring period of 4 weeks to guide rate control therapy compared to the delayed cardioversion approach.
Main study parameters/endpoints: The primary endpoint is the presence of sinus rhythm on the ECG at 4 weeks. Secondary endpoints are implementation of telemonitoring infrastructure, AF recurrences and progression, adverse events, cost-effectiveness, and quality of life.