Early Atrial Fibrillation Ablation for Stroke Prevention
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
Recruiting
N/AInterventional Study
Atrial Fibrillation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
2,312 (estimated)
Sponsor
Atrial Fibrillation Network · Other
Who this trial is looking for
This trial is looking for patients with atrial fibrillation and other health issues. Participants will receive an early treatment to see if it helps prevent serious heart problems compared to regular care.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with atrial fibrillation in the last 5 years.
I have a high comorbidity score of 4 or more.
I am at least 18 years old.
I can provide signed consent for participation.
You may not be able to join if
I have a disease that affects my life expectancy to less than 1 year.
I am currently pregnant or breastfeeding.
I have a history of stroke in the last 3 months.
I have had previous ablation for atrial fibrillation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 hear…
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.
Trial Locations
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Eligibility Criteria
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…
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.
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