Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
Recruiting · NCT04559243 · Observational (researchers observe without assigning treatment) · Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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;
- 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;
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
Where it is running
5 locations listed.
- Qilu Hospital of Shandong University - Jinan, Shandong, China
- Shanghai Songjiang District Central Hospital - Shanghai, Shanghai Municipality, China
- Sichuan Mianyang 404 Hospital - Mianyang, Sichuan, China
- The first Affiliated Hospital of WMU - Wenzhou, Zhejiang, China
- The Second Affiliated Hospital and Yuying Children's Hospital of WMU - Wenzhou, Zhejiang, China