Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure

Ki vehet részt

• Patient has documented non-valvular atrial fibrillation (i.e, atrial fibrillation without severe mitral stenosis or mechanical valves)
• Patient has CHA2DS2-VA score of 2 or greater
• Patient meets the guidelines for proper use of the left atrial appendage closure system including patient who has an increased risk of bleeding
• Individual with nonvalvular atrial fibrillation who underwent successful LAAC (defined as no significant residual circumferential leak [>3 mm] or major morbidity by the time of procedure completion)
• Patient suitable for pharmacotherapy as defined in this study protocol in both NAPT and SAPT arms
• LAA anatomy is accommodate Boston Scientific WATCHMAN FLX Pro and LAAC procedure
• The patient and the investigator and/or subinvestigator agree that the patient will return for all required VISITs after LAAC procedure
• Patient has thoroughly understood the purpose of the study and has provided written informed consent to participate in the study

Ki nem vehet részt

• Individuals require long-term anticoagulation therapy for reasons other than atrial fibrillation (AF)-related stroke risk reduction (e.g.,thrombophilic conditions, previous pulmonary embolism, or deep venous thrombosis)
• Those who have or are scheduled to undergo cardiac or noncardiac intervention or surgery 45 days or 60 days before or after LAAC (e.g.,cardioversion, PCI, cardiac ablation, cataract surgery, other structural heart interventions)
• Patients with stroke (either ischemic or hemorrhagic) or transient ischemic attack within 30 days prior to enrollment
• Individuals who experienced a myocardial infarction (with or without intervention) recorded as a non-ST elevation myocardial infarction or ST elevation myocardial infarction in the 30-day period prior to enrollment
• Patients with previous atrial septal repair or with atrial septal defect/patent foramen ovale device
• Patients requiring emergency surgery for any reason
• Patients requiring oral antiplatelet therapy for reasons other than LAAC (e.g.,history of myocardial infarction, history of endovascular treatment, history of stroke/transient ischemic attack, significant coronary stenosis proven by myocardial ischemia, severe carotid stenosis requiring invasive treatment,hematologic disease such as antiphospholipid syndrome or if the investigator and/or subinvestigator judged the need for antiplatelet therapy)
• Patients who meet one or more of the following criteria; Patients who are contraindicated for DOAC or VKA; Patients with a contraindication to aspirin; Patients diagnosed with an allergy to aspirin
• Patients with active bleeding
• Patients with active infection
• Individuals with NYHA class related IV congestive heart failure at enrollment
• Patients who, at the discretion of the investigator, have other medical, social, or psychological conditions that preclude adherence to appropriate consent or the follow-up tests required by the protocol
• Patients who are currently enrolled in other clinical trials, except when the patient is participating in a mandatory governmental registries or purely observational registries with no associated treatment
• Individuals who lack LAA or whose LAA has been surgically ligated
• Patients with mechanical valve prostheses at any site
• Persons with known contraindications to TEE
• Patients who are pregnant, breastfeeding, or wishing to become pregnant
• Patients with an expected life expectancy of less than 2 years
• Other patients whose investigator or subinvestigator judges their participation in the study to be inappropriate