Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
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
Lifetech Scientific (Shenzhen) Co., Ltd.
579 participants
Nov 12, 2020
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria11
- 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
Interventions
After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT04559243