Actively Recruiting
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
Led by Atrial Fibrillation Network · Updated on 2026-01-08
2312
Participants Needed
7
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Atrial fibrillation first diagnosed within 5 years before enrollment and documented by ECG
- CHA2DS2-VASc score of 4 or more indicating high comorbidity
- Suitable for ablation using cryoballoon or other similar ablation systems from Medtronic
- Age 18 years or older
- Signed informed consent provided
You will not qualify if you...
- Any disease limiting life expectancy to less than 1 year
- Participation in another clinical trial within 3 months before enrollment or ongoing (sub-studies related to this trial are allowed)
- Previous participation in EASThigh-AFNET 11 trial
- Pregnant women
- Breastfeeding women
- Drug abuse or clinically manifest alcohol abuse
- Prior atrial fibrillation ablation or surgical therapy for AF
- Not suitable for atrial fibrillation ablation
- History of stroke within 3 months before enrollment
- Valve disease requiring specific therapy
- Clinically significant thyroid dysfunction requiring treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Several sites
Multiple Locations, Australia
Not Yet Recruiting
2
Several sites
Multiple Locations, Canada
Actively Recruiting
3
Several sites
Multiple Locations, Germany
Actively Recruiting
4
Several sites
Multiple Locations, Netherlands
Actively Recruiting
5
Several sites
Multiple Locations, Poland
Actively Recruiting
6
Several sites
Multiple Locations, Spain
Actively Recruiting
7
Several sites
Multiple Locations, United Kingdom
Not Yet Recruiting
Research Team
A
Antje Albring, Dr.
CONTACT
A
Anna-Katharina Quade
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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