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.
Atrial Fibrillation (AF) is associated with high morbidity and mortality. Even on optimal anticoagulation and therapy of concomitant conditions, many patients with AF suffer cardiovascular events, especially heart failure events, stroke, and cardiovascular death. Most of these events occur in elderly patients with comorbidities. Early rhythm control, mainly delivered using antiarrhythmic drugs, reduces AF-related complications when added to anticoagulation, rate control, and treatment of comorbidities when compared to current practice that offers rhythm control mainly to reduce symptoms. The outcome-reducing effect of early rhythm control is most pronounced in patients with multiple comorbidities, quantified by a CHA2DS2-VASc score ≥ 4. Attaining sinus rhythm is the key mediator for the outcome-reducing effect of early rhythm control. Atrial fibrillation ablation controls the rhythm better than drug-based rhythm control, avoids long-term antiarrhythmic drug treatment, thus reducing polypharmacy, and may therefore be the ideal rhythm control treatment in patients with AF and a high comorbidity burden. This hypothesis needs testing. The investigator-initiated EASThigh-AFNET 11 trial evaluates the effectiveness and safety of early atrial fibrillation ablation in patients with recently diagnosed AF and a high comorbidity burden. EASThigh-AFNET 11 is a Treatment Strategy trial randomizing 2312 patients with AF and a high comorbidity burden to early atrial fibrillation ablation or usual care to achieve a fixed number of primary endpoint events of n=527. All therapies are clinically approved. The primary outcome is a composite of cardiovascular death, stroke, and hospitalization for worsening of heart failure. The primary safety outcome is a composite of all-cause death and serious complications of AF therapy. Secondary outcome parameters address safety, patient reported outcomes and cognitive function. EASThigh-AFNET 11 was recommended for funding by the Expert Advisory Panel of the Global Cardiovascular Research Funders Forum (GCRFF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,312
Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.
Usual 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.
Several sites
Multiple Locations, Australia
NOT_YET_RECRUITINGSeveral sites
Multiple Locations, Canada
RECRUITINGSeveral sites
Multiple Locations, Germany
RECRUITINGSeveral sites
Multiple Locations, Netherlands
RECRUITINGSeveral sites
Multiple Locations, Poland
RECRUITINGSeveral sites
Multiple Locations, Spain
RECRUITINGSeveral sites
Multiple Locations, United Kingdom
NOT_YET_RECRUITINGComposite 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.
Time frame: Throughout study completion, estimated at a mean of 4 years
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.
Time frame: Throughout study completion, estimated at a mean of 4 years
Number of nights spent in hospital
Time frame: Throughout study completion, estimated at a mean of 4 years
Time from randomisation to first occurrence of each of the individual components of the primary outcome
Time frame: Throughout study completion, estimated at a mean of 4 years
All-cause death
Time frame: Throughout study completion, estimated at a mean of 4 years
Serious adverse events related to AF therapy
Time frame: Throughout study completion, estimated at a mean of 4 years
Time from randomisation to first cardiovascular hospitalisation
Time frame: Throughout study completion, estimated at a mean of 4 years
Number of cardiovascular hospitalisations (over-night stay)
Time frame: Throughout study completion, estimated at a mean of 4 years
Changes in left ventricular ejection fraction
Time frame: comparing baseline with 24 months follow up (FU)
Changes in quality of life
assessed by EQ-5D-5L
Time frame: comparing baseline with 12 and 24 months FU
Changes in quality of life
assessed by AFEQT
Time frame: comparing baseline with 12 and 24 months FU
Changes in cognitive function
assessed by Montreal-Cognitive-Assessment-Test
Time frame: comparing baseline with 24 months FU
Cardiac rhythm status
sinus rhythm compared to AF
Time frame: at 12 and 24 months FU
AF pattern
Time frame: at 12 and 24 months FU
Time from randomisation to first clinical recurrence of AF
Time frame: Throughout study completion, estimated at a mean of 4 years
Time from randomisation to first progression of AF
i. e. from paroxysmal to persistent or longstanding persistent or permanent and each of these components
Time frame: Throughout study completion, estimated at a mean of 4 years
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