The Dutch CardioVascular Alliance (DCVA), Innovative Medical Devices Initiative (IMDI), Hartstichting, ZonMw and NWO granted the study "Device-based rate versus rhythm control treatment in patients with symptomatic recent-onset atrial fibrillation in the emergency department". The study is part of the call "Hart voor Duurzame zorg". Prof. H.J.G.M. Crijns and Drs. N.A.H.A. Pluymaekers are leading the project and YourRhythmics is one of the industrial partners.
Continuous heart rhythm monitoring elucidated the recurrent and transient nature of recent-onset atrial fibrillation (AF). Earlier studies showed that a wait-and-see approach (WAS) in patients with recent-onset AF allows spontaneous conversion to sinus rhythm in 69% of patients, obviating active cardioversion. Recurrences within one month were seen in 30% of patients in both groups, i.e. the initially chosen strategy did not affect the recurrence pattern. Considering the latter, it remains unclear whether cardioversion is needed at all, especially since cardioversion strategy does not seem to affect behaviour of the arrhythmia over time.
Instead of cardioversion a watchful-waiting rate control strategy may be appropriate as initial strategy. Therefore, the partner in the project intend to perform a multi-center clinical randomized controlled trial to show non-inferiority of watchful-waiting with rate control versus the WAS approach in terms of prevalence of sinus rhythm at 4 weeks follow-up, using a novel infrastructure to guide rate, measure AF complexity and rhythm control during follow-up. This novel telemonitoring infrastructure may facilitate the watchful-waiting strategy and obviate the need for cardioversion and reduce costs compared to the delayed rhythm control WAS strategy.
The project "Device-based rate versus rhythm control treatment in patients with symptomatic recent-onset atrial fibrillation in the emergency department" is a collaboration between MUMC+, VU medical center, UMC Groningen, Radboud UMC, Viecur MC, Zuyderland MC, Elisabeth Tweesteden hospital, Antonius hospital Sneek, St. Antonius hospital Nieuwegein, Medical Spectrum Twente, Martini hospital Groningen, Rijnstate hospital Arnhem, Amphia hospital Breda, Alrijne hospital Leiderdorp, Applied Biomedical Systems and YourRhythmics.