Early Heart Rhythm Ablation Compared With Usual Care for Irregular Heartbeat
Tests early ablation for atrial fibrillation in adults with many other health conditions.
Plain-language title generated from the registry record
Registry title: Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
Key facts
- Where
- Multiple Locations, GermanySee the site
Where in Germany
- Multiple LocationsMultiple Locations, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Atrial Fibrillation Network
- Trial code
- NCT06324188
- Record updated
- 8 January 2026
- Original description
EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).Read full original descriptionShow less
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
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: 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: 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; E6. Drug abuse or clinically manifest alcohol abuse; E7. Prior AF ablation or surgical therapy of AF; E9. Patients with a history of stroke which occurred within 3 months prior to enrolment; E11. Clinically manifested thyroid dysfunction requiring therapy; E1. Any disease that limits life expectancy to less than 1 year; E10. Valve disease requiring specific therapy; General exclusion criteria; E4. Pregnant women; E5. Breastfeeding women; E8. Patients not suitable for AF ablation.