No registrations found.
ID
Source
Brief title
Health condition
Atrial fibrillation
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence of sinus rhythm on ECG after 4 weeks
Secondary outcome
Implementation of the telemonitoring infrastructure, MACCE, AF recurrences/progression, cost-effectiveness, quality of life, patient reported outcome measures
Background 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 and rhythm control during follow-up.
Study objective
The watchful waiting strategy is non-inferior compared to routine care in terms of effectiveness (presence of sinus rhythm on ECG after 4 weeks) in patients with recent-onset, symptomatic atrial fibrillation.
Study design
Patients will have a follow-up visit after 4 weeks. Total follow-up duration will be one year.
Intervention
watchful waiting
Inclusion criteria
Age > 18 years, ECG with atrial fibrillation, duration current episode <36 hours, symptoms due to AF, able and willing to sign informed consent, able and willing to use telemonitoring infrastructure
Exclusion criteria
History of persistent AF, signs of myocardial infarction, signs of acute heart failure, hemodynamic instability, history of (untreated) sick sinus syndrome or Wolff-Parkinson-White syndrome, history of (unexplained) syncope, deemed unsuitable by attending physician, currently enrolled in another clinical trial
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9416 |
| Other | METC UM/aZM : METC 20-017 |