Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation

• Status: Completed
• Trial end date: 2019-07-20
• Target enrollment: 0
• Participant gender: All

Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence of 1-2%. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5-6%. The source of a cardioembolic event is a thrombus, which usually forms in the left atrial appendage (LAA). The prevention of cardioembolic events involves treatment with anticoagulant drugs, which were limited to, until recently, vitamin K antagonists (e.g. warfarin). Anticoagulant treatment with warfarin can lead to adverse bleeding events, some of which can be life threatening. Recently, two new options for thrombus prevention have been developed. The first is the novel anticoagulants (NOAC), which were associated with slightly better safety profiles due to a lower frequency of intracranial bleeding in large randomized trials . The second option involves interventional occlusion of the LAA. The aim of this project is to compare the LAA occlusion intervention to NOAC pharmacological treatment in a randomized multicenter study of AF patients at high risk of a cardioembolic event.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charles University, Czech Republic
• Collaborator: Ministry of Health, Czech Republic
• Treatments: Anticoagulants

Criteria

Inclusion Criteria:

1. history of significant bleeding (i.e. bleeding which required intervention or hospitalization), even in the absence of anticoagulation treatment at the time of the bleeding event, or

2. a cardioembolic event, which occurred on anticoagulation, or

3. a high risk profile of the patient, defined as a CHA2DS2-VASc score ≥ 3 and a HAS-BLED score ≥ 2

Exclusion Criteria:

1. thrombus in the LA or LAA;

2. mechanical valve prosthesis;

3. mitral stenosis;

4. previous LAA ligation during cardiac surgery;

5. life expectancy less than 2 years;

6. comorbidities other than AF, which present an indication for anticoagulation;

7. patent foramen ovale with atrial septal aneurysm

8. mobile plaque in the aorta;

9. symptomatic atherosclerosis of the carotid artery;

10. pericardial effusion greater than 10 mm;

11. clinically significant bleeding within the 30 days prior to the scheduled procedure;

12. stroke or other cardioembolic event within the 30 days prior to the scheduled procedure;

13. acute coronary syndrome within the 90 days prior to the scheduled procedure,

14. gravidity,

15. significant valvular disease,

16. creatinine clearance less than 30 ml/min