Atrial Fibrillation
Conditions
Keywords
Early atrial fibrillation ablation, High comorbidity burden, CHA2DS2-VASc score, Early rhythm control, Stroke, Heart failure, Cardiovascular death, Cryoballoon
Brief summary
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.
Detailed description
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).
Interventions
OTHEREarly atrial fibrillation ablation
Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.
OTHERUsual Care
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.
Sponsors
Atrial Fibrillation Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
blinded endpoint assessment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
I1. AF first diagnosed within 5 years prior to enrolment and documented in body surface ECG I2. High comorbidity estimated by CHA2DS2-VASc score of 4 or more I3. Patient suitable for ablation using cryoballoon ablation systems or other ablation systems with comparable efficacy and safety from Medtronic I4. Age ≥ 18 years I5. Provision of signed informed consent
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of cardiovascular complications related to AF | Throughout study completion, estimated at a mean of 4 years | 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. | Throughout study completion, estimated at a mean of 4 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death | Throughout study completion, estimated at a mean of 4 years | — |
| Serious adverse events related to AF therapy | Throughout study completion, estimated at a mean of 4 years | — |
| Time from randomisation to first cardiovascular hospitalisation | Throughout study completion, estimated at a mean of 4 years | — |
| Number of cardiovascular hospitalisations (over-night stay) | Throughout study completion, estimated at a mean of 4 years | — |
| Changes in left ventricular ejection fraction | comparing baseline with 24 months follow up (FU) | — |
| Number of nights spent in hospital | Throughout study completion, estimated at a mean of 4 years | — |
| Changes in cognitive function | comparing baseline with 24 months FU | assessed by Montreal-Cognitive-Assessment-Test |
| Cardiac rhythm status | at 12 and 24 months FU | sinus rhythm compared to AF |
| AF pattern | at 12 and 24 months FU | — |
| Time from randomisation to first clinical recurrence of AF | Throughout study completion, estimated at a mean of 4 years | — |
| Time from randomisation to first progression of AF | Throughout study completion, estimated at a mean of 4 years | i. e. from paroxysmal to persistent or longstanding persistent or permanent and each of these components |
| Changes in quality of life | comparing baseline with 12 and 24 months FU | assessed by EQ-5D-5L |
| Time from randomisation to first occurrence of each of the individual components of the primary outcome | Throughout study completion, estimated at a mean of 4 years | — |
Countries
Australia, Canada, Germany, Netherlands, Poland, Spain, United Kingdom
Contacts
Primary ContactAntje Albring, Dr.
Backup ContactAnna-Katharina Quade
Outcome results
None listed