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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with non-valvular atrial fibrillation and previous AF-related embolic events
Trial design
Design model
Ecologic or community
Time perspective
Prospective
Treatments tested in this trial
Transthoracic Echocardiography
Diagnostic testAfter the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation
Ischemic stroke, systemic embolism, and cardiac death events
Time frame
12 months2
Incidence of major bleeding events (intracranial or gastrointestinal, or any bleeding requiring transfusion of ≥ 2 units of red blood cells) at 12 months after operation
Bleeding events
Time frame
12 monthsSecondary outcomes
1
Surgical success rate
Surgical success
Time frame
24 months2
Success rate of LAA closure at 3 months after operation
Successful LAA closure was defined as a residual shunt ≤ 3 mm by TEE or ICE after implantation of the LAA occluder.
Time frame
3 months3
The composite endpoint of new ischemic stroke, systemic embolism and cardiac death at 7 months after operation or before discharge and at 1, 3, 6 and 24 months after operation
Ischemic stroke, systemic embolism, and cardiac death events
Time frame
24 months4
(4)Perioperative (7 days after operation or before discharge) surgery-related complications
7 days after operation or pre-discharge procedure-related complications include but are not limited to stroke (ischemic and hemorrhagic stroke), systemic embolism, allergic reaction, gas embolism, pericardial effusion/cardiac tamponade requiring intervention, occluder detachment, occluder thrombosis (DRT), minor bleeding events (including but not limited to puncture site hematoma, non-major bleeding events), infection, arrhythmia, damage to blood vessels or organs on the implantation path and adjacent organs
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov