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

Recruitingn/aAges 18 Years - anyAllLifetech Scientific (Shenzhen) Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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; 1. HAS-BLED bleeding risk score ≥ 3 points; 2. Not suitable for long-term oral anticoagulant therapy; 3. Poor compliance with oral anticoagulants; 4. CHA2DS2-VASc score ≧ 2 points; Exclusion Criteria: * 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 * ST elevation myocardial infarction, ≤ 3 months * Grade-IV of Cardiac Function (NYHA) * Allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, and other anticoagulants * Pregnant or with plan of pregnancy during the study * Participation in another drug or medical device clinical trial or study that has not been completed * Experience new stroke or TI within 30 days or major bleeding events within 14 days * Contraindication to LAA closure or deemed unsuitable for study participation by the investigator * Had a definite thromboembolic event
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What it tests

  • Transthoracic Echocardiography
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Where

5 sites
Qilu Hospital of Shandong University
Jinan, China
Shanghai Songjiang District Central Hospital
Shanghai, China
Sichuan Mianyang 404 Hospital
Mianyang, China
The first Affiliated Hospital of WMU
Wenzhou, China
The Second Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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