A Prospective, Multicenter Clinical Study of Percutaneous Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events in Patients With Atrial Fibrillation
This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System. 579 patients with valvular AF complicated with previous AF-related embolic events (including ischemic stroke, TIA and systemic embolism) were enrolled at about 20 study sites nationwide. The baseline data, operation process and relevant follow-up information of subjects were recorded at 7 months after operation or before discharge and at 1, 3, 6, 12 and 24 months after operation.
• 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;