EASThigh

Study design

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.

Inclusion Criteria

AF first diagnosed within 5 years prior to enrolment and documented in body surface ECG

High comorbidity estimated by CHA2DS2-VASc score of 4 or more

Patient suitable for ablation using cryoballoon ablation systems or other ablation system with comparable efficacy and safety from Medtronic

Age ≥ 18 years

Provision of signed informed consent

General exclusion criteria

Any disease that limits life expectancy to less than 1 year.

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).

Previous participation in EASThigh-AFNET 11.

Pregnant women.

Breastfeeding women.

Drug abuse or clinically manifest alcohol abuse.

Exclusion criteria related to a cardiac condition

Prior AF ablation or surgical therapy of AF.

Patients not suitable for AF ablation.

Patients with a history of stroke which occurred within 3 months prior to enrolment.

Valve disease requiring specific therapy.

Exclusion criteria based on laboratory abnormalities