Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Cardiac arrhythmia, Cardioversion, Electrical cardioversion, Watchful waiting, Wait-and-see, Telemonitoring
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
Sites / Locations
- Maastricht University Medical CenterRecruiting
- Noordwest ZiekenhuisgroepRecruiting
- Vrije Universiteit Medisch CentrumRecruiting
- RijnstateRecruiting
- Medisch Spectrum TwenteRecruiting
- Martini ZiekenhuisRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- Zuyderland Medisch CentrumRecruiting
- Alrijne ZiekenhuisRecruiting
- St Antonius ZiekenhuisRecruiting
- Radboud UMCRecruiting
- Antonius ZiekenhuisRecruiting
- St. Elisabeth TweeSteden ZiekenhuisRecruiting
- VieCuri Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Watchful waiting
Routine care
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.
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.