EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).
The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.
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Parallel
Early atrial fibrillation ablation
Other interventionPatients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.
Usual Care
Other interventionUsual care will consist of optimal AF therapy based on guideline recommendations and local protocols and usage.The choice of therapies and medications follows routine care in line with medical guidelines and local policies at the discretion of the treating physician and should be based on the individual medical status of each study patient.
Composite of cardiovascular complications related to AF
It is defined as time from randomisation to the first occurrence of a composite of cardiovascular death, stroke (either ischemic or hemorrhagic), or hospitalisation for worsening of heart failure.
The primary safety outcome is a composite of all-cause death and serious complications of AF therapy.
Serious Adverse Events (SAEs), including primary and secondary outcome parameters if based on clinical events, will be adjudicated by the independent Clinical Event Committee (CEC) according to standardised definitions given in the CEC charter.
Number of nights spent in hospital
Time from randomisation to first occurrence of each of the individual components of the primary outcome
All-cause death
Serious adverse events related to AF therapy
Map coordinates are unavailable for these locations. Locations are shown below instead.
Australia
Canada
Germany
NetherlandsClick on the lead sponsor to view all of their trials.
