Early atrial fibrillation ablation: Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.
Usual 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 exclusion criteria
E1. Any disease that limits life expectancy to less than 1 year.
E2. Participation in another clinical trial, either within the 3 months prior to enrolment or still on-going (participation in potential sub-studies connected to this trial is permitted).
E3. Previous participation in EASThigh-AFNET 11.
E4. Pregnant women.
E5. Breastfeeding women.
E6. Drug abuse or clinically manifest alcohol abuse.
Exclusion criteria related to a cardiac condition
E7. Prior AF ablation or surgical therapy of AF.
E8. Patients not suitable for AF ablation.
E9. Patients with a history of stroke which occurred within 3 months prior to enrolment.
E10. Valve disease requiring specific therapy.
Exclusion criteria based on laboratory abnormalities
E11. Clinically manifested thyroid dysfunction requiring therapy.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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