Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
Recruiting · NCT06324188 · Interventional (participants receive a specific treatment) · Lead sponsor: Atrial Fibrillation Network
View the official record on ClinicalTrials.gov →Interventions studied
Early atrial fibrillation ablationUsual Care
What this trial 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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
14 locations listed.
- 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
- 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