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Updated: Mar 10, 2026
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation
Pavel Osmancik1, Petr Tousek1, Dalibor Herman1
1Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
Insights
Percutaneous left atrial appendage (LAA) occlusion is being compared to novel oral anticoagulants (NOAC) for preventing cardioembolic events in atrial fibrillation (AF) patients. This trial will determine if LAA occlusion is a noninferior alternative to NOAC therapy.
Area of Science:
- Cardiology
- Interventional Cardiology
- Electrophysiology
Background:
- Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting 1-2% of the population.
- Cardioembolic events, often originating from the left atrial appendage (LAA), pose a significant risk (5-6% annually) without antithrombotic treatment.
- Current prevention strategies include vitamin K antagonists, novel oral anticoagulants (NOAC), and interventional LAA occlusion.
Purpose of the Study:
- To evaluate if percutaneous LAA occlusion is noninferior to NOAC treatment in AF patients requiring long-term anticoagulation.
- To compare the efficacy and safety of LAA occlusion versus NOACs in preventing cardioembolic events and other adverse outcomes.
Main Methods:
- A prospective, multicenter, randomized noninferiority trial (PRAGUE-17).
- Comparison of percutaneous LAA occlusion versus NOAC treatment in 396 moderate- to high-risk AF patients.
- Primary endpoint: composite of stroke, systemic cardioembolic event, significant bleeding, cardiovascular death, or device/procedural complications within 24 months.
Main Results:
- The PRAGUE-17 trial is designed to determine noninferiority but results are not yet available in the abstract.
- The study aims to provide crucial data on LAA occlusion as an alternative to NOACs.
Conclusions:
- The PRAGUE-17 trial will establish whether LAA occlusion is a noninferior alternative to NOACs for stroke prevention in AF patients.
- Findings will inform clinical practice regarding nonpharmacologic stroke prevention strategies in AF.
Abstract:
Atrial fibrillation (AF), with a prevalence of 1% to 2%, is the most common cardiac arrhythmia. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5% to 6%. The source of a cardioembolic event is a thrombus, which is usually formed in the left atrial appendage (LAA). Prevention of cardioembolic events involves treatment with anticoagulant drugs: either vitamin K antagonists or, recently, novel oral anticoagulants (NOAC). The other (nonpharmacologic) option for the prevention of a cardioembolic event involves interventional occlusion of the LAA.
Objective:
To determine whether percutaneous LAA occlusion is noninferior to treatment with NOAC in AF patients indicated for long-term systemic anticoagulation.
Study Design:
The trial will be a prospective, multicenter, randomized noninferiority trial comparing 2 treatment strategies in moderate to high-risk AF patients (ie, patients with history of significant bleeding, or history of cardiovascular event(s), or a with CHA2DS2VASc ≥3 and HAS-BLED score ≥2). Patients will be randomized into a percutaneous LAA occlusion (group A) or a NOAC treatment (group B) in a 1:1 ratio; the randomization was done using Web-based randomization software. A total of 396 study participants (198 patients in each group) will be enrolled in the study. The primary end point will be the occurrence of any of the following events within 24months after randomization: stroke or transient ischemic attack (any type), systemic cardioembolic event, clinically significant bleeding, cardiovascular death, or a significant periprocedural or device-related complications.
Conclusion:
The PRAGUE-17 trial will determine if LAA occlusion is noninferior to treatment with NOAC in moderate- to high-risk AF patients.
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