Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
Recruiting now NCT06324188
Run by Atrial Fibrillation Network · for 18 and older · All sexes
What this study is about
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.
Who can join (things the study team will check)
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 ma…
Where this trial is running
- Several sites, Multiple Locations, Australia
- Several sites, Multiple Locations, Canada
- Several sites, Multiple Locations, Germany
- Several sites, Multiple Locations, Netherlands
- Several sites, Multiple Locations, Poland
- Several sites, Multiple Locations, Spain
- Several sites, Multiple Locations, United Kingdom
Who to contact
Antje Albring, Dr. · +49 251 980 1330 · easthigh@af-net.eu
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06324188.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.