NCT06324188Recruiting
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2312 (estimated)
- First submitted
- 4 Mar 2024
- Start date
- 14 Oct 2024
- Primary completion date
- Feb 2030
- Lead sponsor
- Atrial Fibrillation Network
- Diseases
- Heart failure, Stroke, Atrial fibrillation
- NCT number
- NCT06324188
What you commit to
- Study type: Interventional
- Planned participants: 2312
- From 14 Oct 2024 to the primary completion date, Feb 2030
- 7 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- E1. Any disease that limits life expectancy to less than 1 year.
- E10. Valve disease requiring specific therapy.
Other
- General exclusion criteria
- E4. Pregnant women.
- E5. Breastfeeding women.
- E8. Patients not suitable for AF ablation.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Multiple Locations | Australia | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Multiple Locations | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Multiple Locations | Germany | Recruiting |
| - Coordinator of this site? Confirm its status | Multiple Locations | Spain | Recruiting |
| - Coordinator of this site? Confirm its status | Multiple Locations | United Kingdom | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Multiple Locations | Netherlands | Recruiting |
| - Coordinator of this site? Confirm its status | Multiple Locations | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.