LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.
Non-paroxysmal Atrial Fibrillation
About this trial
This is an interventional prevention trial for Non-paroxysmal Atrial Fibrillation focused on measuring left atrial appendage clipping, Stroke, Oral anticoagulation, Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years. Persistent or long-standing persistent AF documented by medical history or direct electrocardiogram. CHA2DS2-VASc ≥2 in men and ≥3 in women. Agree to perform thoracoscopic LAA occlusion procedure. Exclusion Criteria: With electrical cardioversion or ablation intent. Other heart diseases with surgical indications. Ischemic stroke and other cardiac embolic events within 30 days. Major clinical bleeding event within 30 days. Contraindications to anticoagulation. Intracardiac thrombus. Left ventricular ejection fraction (LVEF) < 30%. Active systemic infection or infective endocarditis or pericarditis Severe liver disease (acute clinical hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT)/ aspartate transaminase (AST) greater than 3 times the upper limit of normal value. Severe renal insufficiency (eGFR ≤ 30mL/min). Other diseases requiring oral anticoagulants. Active aortic plaque. Acute coronary syndrome within 3 months. Symptomatic carotid artery stenosis. Patients requiring dual antiplatelet drug therapy. Previous cardiac and left lung surgery. Severe left pleural and pericardial adhesions. Pregnant or breastfeeding patients. Metal allergies. Terminal illness with a life expectancy of less than 2 years. Participation in other clinical studies at the time of enrollment. Refuse to participate in this study.
Sites / Locations
- China National Center for Cardiovascular Diseases
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
LAA clipping group
NOACs group
In this arm, participants are performed thoracoscopic LAA clipping.
Patients randomized to NOAC therapy will begin long-term oral administration of NOACs immediately after enrollment.