Device-based Rate Versus Rhythm Control Treatment in Patients With Symptomatic Recent-onset Atrial Fibrillation in the Emergency Department (RACE 9 OBSERVE-AF)

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Continuous heart rhythm monitoring elucidated the recurrent and transient nature of recent-onset atrial fibrillation (AF). The RACE7 ACWAS 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. This allows observing the electrical and clinical behavior of arrhythmia, providing a solid basis for comprehensive and effective early rhythm control. This study is a multi-center clinical randomized controlled trial to show non-inferiority of watchful-waiting with rate control versus routine care in terms of prevalence of sinus rhythm at 4 weeks follow-up, using a novel telemonitoring infrastructure to guide rate control during follow-up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ECG with atrial fibrillation

• Duration of the current AF episode \<36 hours

• Symptoms due to atrial fibrillation

• Age \> 18 years

• Able and willing to sign informed consent

• Able and willing to use telemetric rhythm recorder

Locations
Other Locations
Netherlands
Noordwest Ziekenhuisgroep
RECRUITING
Alkmaar
Vrije Universiteit Medisch Centrum
RECRUITING
Amsterdam
Rijnstate
RECRUITING
Arnhem
Medisch Spectrum Twente
RECRUITING
Enschede
Martini Ziekenhuis
RECRUITING
Groningen
Universitair Medisch Centrum Groningen
RECRUITING
Groningen
Zuyderland Medisch Centrum
RECRUITING
Heerlen
Alrijne Ziekenhuis
RECRUITING
Leiderdorp
Maastricht University Medical Center
RECRUITING
Maastricht
St Antonius Ziekenhuis
RECRUITING
Nieuwegein
Radboud UMC
RECRUITING
Nijmegen
Antonius Ziekenhuis
RECRUITING
Sneek
St. Elisabeth TweeSteden Ziekenhuis
RECRUITING
Tilburg
VieCuri Medical Centre
RECRUITING
Venlo
Contact Information
Primary
Rachel MJ van der Velden, MD
rachel.vander.velden@mumc.nl
31433876885
Backup
Nikki AH Pluymaekers, MD
nikki.pluymaekers@mumc.nl
31433875119
Time Frame
Start Date: 2020-11-16
Estimated Completion Date: 2025-06
Participants
Target number of participants: 490
Treatments
Experimental: Watchful waiting
the watchful-waiting approach consists 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 four weeks to guide rate control therapy.
Other: Routine care
Routine care consists of the standard treatment for an acute episode of recent-onset symptomatic atrial fibrillation, namely acute or delayed cardioversion, followed by a telemetric rhythm monitoring period of four weeks to guide rate control therapy.
Related Therapeutic Areas
Sponsors
Collaborators: Dutch Heart Foundation, Netherlands Organisation for Scientific Research, ZonMw: The Netherlands Organisation for Health Research and Development
Leads: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov