Comparing left atrial appendage occlusion to novel oral anticoagulation for preventing strokes in atrial fibrillation patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of left atrial appendage occlusion (LAAO) compared to novel oral anticoagulants (NOAC) in preventing strokes and other serious outcomes in patients with atrial fibrillation who have experienced a prior ischemic stroke or transient ischemic attack. It is a multicenter, randomized, open-label trial designed to assess the non-inferiority of LAAO against NOAC therapy. A total of 750 patients will be enrolled, and outcomes will be evaluated over a follow-up period of up to 10 years through both in-office visits and national patient registries. The primary outcome will focus on a composite of stroke, systemic embolism, major bleeding, and all-cause mortality.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* documented non-valvular atrial fibrillation (paroxysmal, persistent or permanent)
* Eligible for long-term Novel Oral Anticoagulation (NOAC) therapy
* Ischemic stroke within the recent 6 months verified by neuroimaging, or
* Transient ischemic attack within 6 months with proven cerebral ischemia based on cerebral magnetic resonance imaging (MRI)

Exclusion Criteria:

* Modified rankin scale \> 3 at time of enrollment
* Glomerular filtration rate (GFR) below 15 ml/min/1.73 m2
* Contraindication towards long-term aspirin therapy
* Planned combined cardiovascular interventional procedures at the time of enrollment
* Terminal illness or cancer with life expectancy less than 2 years.

Where it's running

• Aarhus University Hospital
  Aarhus, Central Jutland, Denmark Recruiting
• Aalborg University Hospital
  Aalborg, The North Denmark Region, Denmark Recruiting
• Regional Hospital West Jutland
  Holstebro, Denmark Recruiting
• Helsinki University Central Hospital
  Helsinki, Finland Recruiting
• Jena University Hospital
  Jena, Germany Recruiting
• Haukeland University Hospital
  Bergen, Norway Recruiting

Study contacts

• Study coordinator: Kasper Korsholm, MD
• Email: kasperkorsholm@clin.au.dk
• Phone: 004578452254

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.