Until recently the standard approach of patients with recent-onset atrial fibrillation (AF) involved early cardioversion. In the latest ESC AF guidelines, a delayed cardioversion approach within 48 hours has been added to the recommendations. However, given the self-terminating and recurrent nature of AF, cardioversion may not always be necessary, and rate control medication could suffice to manage symptoms until spontaneous conversion to sinus rhythm occurs.
The Research
Continuous heart rhythm monitoring elucidated the recurrent and transient nature of recent-onset atrial fibrillation (AF). In the RACE7 we showed that a wait-and-see approach (WAS) in patients with recent-onset AF (rate control for symptom relief followed by delayed cardioversion if needed <48h) 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, we 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 telemonitoring
infrastructure to guide rate 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 study will be conducted across multiple centers in the Netherlands, including UMC Groningen, Radboud UMC, Amsterdam UMC, Alrijne Hospital, VieCuri Medical Centre, Zuyderland Medical Centre, Elisabeth-TweeSteden Hospital, Rijnstate Hospital, Martini Hospital, St. Antonius Hospital, Antonius Hospital, Noordwest Hospitalgroup, Medisch Spectrum Twente, and Maastricht University Medical Center.
Origin
This project is funded within the Innovative Medical Devices Initiative (IMDI) program 'Heart for Sustainable Care'. The focus of this program is the development of medical technology for the earlier detection, monitoring, and better treatment of cardiovascular diseases to ensure accessible healthcare and sufficient staffing. The program has been developed en funded by the Dutch Heart Foundation, ZonMw and NWO, who collaborate within the Dutch CardioVascular Alliance.
