Clinical trial NCT04612335: Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)
Official title: Device-based Rate Versus Rhythm Control Treatment in Patients With Symptomatic Recent-onset Atrial Fibrillation in the Emergency Department (RACE 9 OBSERVE-AF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Cardiac arrhythmia
Cardioversion
Electrical cardioversion
Watchful waiting
Wait-and-see
Telemonitoring
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Dutch Heart Foundation
name: Netherlands Organisation for Scientific Research
First posted: 2020-11-02
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. However, 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. The aim of this trial is to evaluate effectiveness (presence of sinus rhythm) of a watchful-waiting approach, i.e. symptom reduction through rate-control medication and monitoring until spontaneous conversion is achieved compared to routine care, consisting of either early or delayed cardioversion. The trial is a multicentre prospective, randomized, open label, non-inferiority trial comparing the interventional watchful-waiting approach to routine care (control).The primary endpoint (presence of sinus rhythm), will be assessed after 4 weeks. The total follow-up time is 1 year.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* History of persistent AF (episode of AF lasting more than 48 hours and terminated by cardioversion)
* Deemed unsuitable for participation by attending physician
* Hemodynamic instability (heart rate \>170 bpm, systolic blood pressure \<100 mmHg)
* Acute heart failure
* Signs of myocardial infarction
* History of syncope of unexplained origin
* History of untreated Sick Sinus Syndrome
* History of untreated Wolff-Parkinson-White syndrome
* Currently enrolled in another clinical trial

Primary outcomes:
measure: Presence of sinus rhythm
timeFrame: 4 weeks after inclusion
Secondary outcomes:
measure: Implementation of the telemonitoring infrastructure
timeFrame: 4 weeks
measure: MACCE: major cardiovascular mortality and cardiovascular and cerebrovascular events
timeFrame: 1 year
measure: AF recurrences/AF progression
timeFrame: 4 weeks and 1 year
measure: Cost-effectiveness
timeFrame: 1 year
measure: Questionnaires on quality of life (SF-36)
timeFrame: 1 year
measure: Patient reported experiences
timeFrame: 1 year
measure: Rate and rhythm control interventions (number of)
timeFrame: 4 weeks
measure: Rhythm control interventions
timeFrame: 1 year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Leiderdorp
country: Netherlands
facility: Alrijne Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: Tilburg
country: Netherlands
facility: St. Elisabeth TweeSteden Ziekenhuis
city: Venlo
country: Netherlands
facility: VieCuri Medical Centre
Study officials:
affiliation: Head of cardiology department, Maastricht University Medical Center
name: Harry JG Crijns, MD, PhD
role: STUDY_CHAIR
affiliation: Head of cardiac electrophysiology, Maastricht University Medical Center
name: Dominik Linz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: