Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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
Trial design
Treatments tested in this trial
- Transthoracic Echocardiography
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov