Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT06324188

Run by

Atrial Fibrillation Network

People needed

2312

Starts

2024-10-14

Expected to finish

2030-05-01

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Several sites — Multiple Locations, Netherlands (enrolling)
• Several sites — Multiple Locations, Canada (enrolling)
• Several sites — Multiple Locations, Germany (enrolling)
• Several sites — Multiple Locations, Poland (enrolling)
• Several sites — Multiple Locations, Spain (enrolling)
• Several sites — Multiple Locations, Australia
• Several sites — Multiple Locations, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.