Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events

Prior treatment

• Participation in another drug or medical device clinical trial or study that has not been completed

Other illness

• ST elevation myocardial infarction, ≤ 3 months
• Grade-IV of Cardiac Function (NYHA)
• Allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, and other anticoagulants
• Experience new stroke or TI within 30 days or major bleeding events within 14 days

Other

• Valvular AF (after moderate to severe mitral stenosis or mechanical valve replacement)
• Initial AF, reversible AF with clear cause
• Presence of adherent thrombus in the left atrium or left ventricular aneurysm thrombus
• Pregnant or with plan of pregnancy during the study
• Contraindication to LAA closure or deemed unsuitable for study participation by the investigator
• Had a definite thromboembolic event

• Age ≥ 18 years, male or female;
• Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form (ICF), and are willing to complete the follow-up as required by the protocol;
• Indications for left atrial appendage closure;
• Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions;
  • HAS-BLED bleeding risk score ≥ 3 points;
  • Not suitable for long-term oral anticoagulant therapy;
  • Poor compliance with oral anticoagulants;
  • CHA2DS2-VASc score ≧ 2 points;