RecruitingNot ApplicableNCT06324188

Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)

Sponsor

Atrial Fibrillation Network

Enrollment

2,312 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria11

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.
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.
E11. Clinically manifested thyroid dysfunction requiring therapy.

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.