Exploratory Observation of Regimens After LAA Occlusion by LAMax LAAC® Device for Subjects With High Risk of Bleeding
Non-valvular Atrial Fibrillation
About this trial
This is an interventional prevention trial for Non-valvular Atrial Fibrillation focused on measuring Atrial Fibrillation, Left Atrial Appendage Closure, Ischemic Stroke, Device-related Thrombosis
Eligibility Criteria
Inclusion Criteria: 1. Patients ≥ 18 years old with non-valvular atrial fibrillation (AF) and CHA2DS2-VASc ≥2; 2. Patients not suitable for long-term standardized anticoagulation, or stroke /embolic events still occurred on the basis of long-term standardized anticoagulation; 3. HAS-BLED ≥ 3; 4. Successful left atrial appendage occlusion with LAMax LAAC® device; 5. Patients and their families fully understand the purpose of the study, voluntarily participate in the study and sign the informed consent form. Exclusion Criteria: 1. Combined with other diseases except AF requiring long-term warfarin or other anticoagulant therapy; 2. Absolute contraindications for anticoagulation therapy or unacceptable bleeding risk with dual antiplatelet therapy; 3. Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization); 4. Occluder dislocation, pericardial effusion (including new pericardial effusion and significantly increased pre-existing pericardial effusion) and other bleeding complications within 24 hours after LAAC; 5. Patients scheduled for catheter ablation after left atrial appendage electrical isolation and during the study; 6. Patients resistant to clopidogrel; 7. Patients requiring elective cardiac surgery; 8. Heart failure NYHA grade IV and not been corrected yet; 9. Patients with AF caused by rheumatic valvular heart disease, degenerative valvular heart disease, congenital valvular heart disease, severe mitral stenosis, aortic stenosis and other valvular diseases; 10. Initial atrial fibrillation, paroxysmal atrial fibrillation with a clear cause such as coronary artery bypass grafting (CABG) < 12 months, hyperthyroidism, etc. 11. Patients with acute myocardial infarction or unstable angina pectoris, or recent myocardial infarction < 12 months; 12. Patients with active bleeding, bleeding constitution or bleeding disorders, coagulation history and unhealed gastrointestinal ulcer; 13. Infective endocarditis, vegetation or other infections causing bacteremia, sepsis; 14. Female patients who are pregnant, lactating, or planning to become pregnant during this study; 15. Patients who have participated in other drug or device clinical trials and have not reached the endpoint; 16. Patients with renal insufficiency (endogenous creatinine clearance < 30ml/min) (using the standard Crockcroft-Gault formula) and/or advanced renal disease requiring dialysis; 17. Severe hepatic dysfunction (AST/ALT greater than 5 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal); 18. Patients considered unsuitable for this study by the investigator. 19. Left atrial appendage has been removed, post heart transplantation, post atrial septal repair, or post occluder implantation; 20. Post prosthetic heart valve replacement; 21. Allergic to or contraindication to metal nickel alloy, aspirin, clopidogrel, contrast agent, heparin and other anticoagulants, etc; 22. Patients who have placed other instruments in the cardiovascular cavity and are unable to place the LAA occluder; 23. LVEF(left ventricular ejection fraction, by Simpson method)<35%; 24. Clear thrombus is found in the heart before LAAC; 25. TEE examination: the maximal orifice diameter of LAA is less than 12 mm, or more than 36 mm; 26. Residual flow after LAAC >5mm; 27. Patent foramen ovale with high risk; 28. Mitral stenosis with a valve area <1.5cm2; 29. Left atrial diameter (antero-posterior diameter) > 65mm, or pericardial effusion more than a small amount, the depth of local effusion > 10 mm; 30. Contraindications to X-ray, or not suitable for TEE examination.
Sites / Locations
- 2nd Affiliated Hospital, School of Medicine at Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Dual antiplatelet
Novel oral anticoagulant
Aspirin 100 mg + clopidogrel 75 mg for 4 weeks post-LAAC; followed by aspirin/clopidogrel for 4-24 weeks post-LAAC; recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).
Conventional dose NOAC for 4 weeks post-LAAC; followed by aspirin/clopidogrel for 4-24 weeks post-LAAC; recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).