Device-based rate versus rhythm control treatment in patients with symptomatic recent-onset atrial fibrillation in the emergency department (RACE 9)
The RACE 9 Observe-AF project aims to investigate the effectiveness of a watchful waiting approach compared to routine care for patients with recent-onset symptomatic atrial fibrillation.
Until recently the standard of care for patients with recent-onset atrial fibrillation (AF) was early cardioversion. In the latest ESC AF guidelines, a delayed cardioversion approach within 48 hours has been added to the recommendations. However, considering the often self-terminating and frequently recurrent nature of AF, cardioversion might not be needed at all and rate control medication might be sufficient to bridge the time until spontaneous conversion to sinus rhythm.
The RACE 9 Observe-AF trial is a multicenter, prospective, randomized, open label non-inferiority trial comparing a watchful waiting approach (intervention) to routine care (control). The watchful waiting approach consists of symptom reduction through rate control medication and monitoring for 4 weeks until possible spontaneous conversion, whereas routine care consists of either early or delayed cardioversion within 48h. The primary endpoint of this non-inferiority study is the presence of sinus rhythm on the ECG after four weeks.
The study will be performed in numerous centers in the Netherlands: 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. This study is sponsored by NWO, ZonMW and the Dutch Heart Foundation.
Maastricht University Medical Center+
Prof. dr. H. (Harry) Crijns, principal investigator, project leader
Dr. D. (Dominik) Linz, co-project leader
Prof. dr. U (Ulrich) Schotten, technical leader
Dr. J. (Justin) Luermans, co-project leader
Dr. E. (Elton) Dudink
Dr. C. (Carsten) Leue
Dr. B. (Brigitte) Essers
Drs. N. (Nikki) Pluymaekers, coordinating investigator
Drs. R. (Rachel) van der Velden, coordinating investigator
Universitair Medisch Centrum Groningen
Prof. dr. I. (Isabelle) van Gelder, co-principal investigator, co-project leader
Prof. dr. M. (Michiel) Rienstra
VieCuri Medical Centre
Dr. W. (Wilfred) Heesen
Dr. J. (Joan) Meeder
Zuyderland Medisch Centrum
Dr. T. (Timo) Lenderink
Radboud Universitair Medisch Centrum
Dr. R. (Rypko) Beukema
St. Elisabeth-TweeSteden Ziekenhuis
Prof. dr. J. (Jos) Widdershoven
Vrij Universiteit Medisch Centrum/Amsterdam UMC
Dr. O. (Otto) Kamp
Prof. dr. J. (Jan) Tijssen
Drs. A. (Toon) Oomen
St. Antonius Ziekenhuis
Dr. V. (Vincent) van Dijk
Medisch Spectrum Twente
Dr. J. (Jurren) van Opstal
Dr. R. (Robert) Tieleman
Dr. M. (Martin) Hemels
Dr. R. (Ron) Pisters
Dr. C. (Charles) Kirchhof
Dr. S. (Stefan) Timmer
Several stakeholders and the potential end-users of our approach are closely involved in the definition of the study deliverables. We implemented an end-user expert committee consisting of seven patients with a history of arrhythmias, a psychiatrist, an advisor concerning privacy and legal considerations, a cardiologist, an AF nurse, a general practitioner, and two experts in implementation of new technologies in hospitals. The user committee has been involved in a pilot study in which the device-based rate and rhythm infrastructure has been tested, has provided us with feedback regarding this infrastructure and has helped us optimize this pathway before the start of the study. In addition, this committee meets on a regular basis in conjunction with the progress of the study and advises the investigators about the implementation of the device-based infrastructure into daily clinical practice after the study.