LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke

This is an interventional prevention trial for Non-valvular Atrial Fibrillation focused on measuring Atrial Fibrillation, Left Atrial Appendage Closure, Ischemic Stroke Read More

Inclusion Criteria:

• Patients ≥ 18 years old with non-valvular atrial fibrillation (AF) and CHA2DS2-VASc ≥2
• There is one of the following: (1) Not suitable for long-term standard anticoagulation treatment; (2) On the basis of long-term standardized anticoagulant therapy with warfarin, stroke or embolism still occurred; (3) HAS-BLED ≥ 3.
• Provide written informed consent and agree to comply with required follow-ups.

Exclusion Criteria:

1. . Patients with other diseases other than AF who need long-term warfarin anticoagulation therapy;
2. . Those who need selective cardiac surgery;
3. . Heart failure NYHA grade IV;
4. . AF caused by rheumatic valvular disease, degenerative valvular disease, congenital valvular disease, severe mitral stenosis, aortic stenosis, or other valvular diseases;
5. . The early onset of AF and paroxysmal AF with definite causes, such as secondary to coronary artery bypass grafting (CABG), hyperthyroidism;
6. . Patients with symptomatic carotid artery disease (such as carotid stenosis > 50%);
7. . Patients with acute myocardial infarction, unstable angina, or recent myocardial infarction < 3 months;
8. . Stroke or TIA within 30 days;
9. . Bleeding disease, coagulation-related diseases, and active peptic ulcer;
10. . Active endocarditis, vegetations, or other infections causing bacteremia or sepsis;
11. . Conditions may lead to difficulty in testing or significantly shorten the life expectancy of patients (< 1 year);
12. . Pregnant, lactating or planned pregnancy during the trial;
13. . Patients who have not reached the end of other clinical trials of drug or device;
14. . Hematological abnormality (WBC < 3 × 109 / L, HB < 90g / L, or platelet count < 50 × 109 / L or > 700 × 109 / L));
15. . Renal insufficiency (creatinine > 3.0mg/dl or 265.2umoi / L), and / or advanced renal diseases requiring dialysis;
16. . Severe liver dysfunction (AST / ALT is 5 times higher than the upper limit of normal value, or total bilirubin is 2 times higher than the upper limit of normal value);
17. . The investigator believes that the patient is not suitable to participate in the clinical trial.
18. . Left atrial appendage has been removed, post heart transplantation, post atrial septal repair, or post occluder implantation;
19. . Radiofrequency ablation in 30 days before and after the implantation of LAA occluder;
20. . Cardioversion within 30 days after the implantation of LAA occluder;
21. . Post prosthetic heart valve replacement;
22. . Allergic to or contraindication to metal nickel alloy, aspirin, clopidogrel, contrast agent, heparin and other anticoagulants, etc;
23. . Patients who have placed other instruments in the cardiovascular cavity and are unable to place the LAA occluder;
24. . LVEF（left ventricular ejection fraction ）<35%；
25. . Clear thrombus is found in the heart before device implantation;
26. . TEE examination: refer to Watchman LAAC requirement to measure the orifice diameter of LAA, the maximum diameter is less than 17 mm, or more than 31 mm;
27. . Patent foramen ovale with high risk;
28. . mitral stenosis with a valve area ≤ 2 cm2;
29. . left atrial 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.