Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation "PRAGUE-17"

Recruiting

Phase 4 Results N/A

Eligibility 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