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

RecruitingNAAges 18 Years - anyAllAtrial Fibrillation Network
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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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What it tests

  • Early atrial fibrillation ablation
  • Usual Care
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Where

7 sites
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
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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