Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
Study Details
Study Description
Brief 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.
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Detailed Description
Study Population Patients with non-valvular atrial fibrillation and previous AF-related embolic events Purpose To assess the feasibility and safety of percutaneous LAA closure as secondary prevention for patients with non-valvular atrial fibrillation (NVAF) and previous atrial fibrillation (AF) related embolic events (including ischemic stroke, transient ischemic attack (TIA), and systemic embolism).
Study Design
Outcome Measures
Primary Outcome Measures
- Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation [12 months]
- 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 [12 months]
Secondary Outcome Measures
- Surgical success rate [24 months]
- Success rate of LAA closure at 3 months after operation [3 months]
Successful LAA closure was defined as a residual shunt ≤ 3 mm by TEE or ICE after implantation of the LAA occluder.
- 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 [24 months]
- (4)Perioperative (7 days after operation or before discharge) surgery-related complications [7 days]
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
- Procedure-related complications during follow-up [24 months]
Follow-up at 1, 3, 6, 12 and 24 months after operation for procedure-related complications, including all-cause death, stroke (ischemic and hemorrhagic stroke), cardiac perforation, pericardial effusion/cardiac tamponade requiring intervention, major bleeding events (intracranial or gastrointestinal, or any bleeding requiring transfusion of ≥ 2 units of red blood cells), occluder thrombosis (DRT), infection, systemic embolism, allergic reaction, arrhythmia, and other serious cardiovascular events requiring intervention or surgical treatment
- Occluder defects during operation and in the 3rd month after operation: including but not limited to occluder displacement, occluder detachment, occluder breakage, occluder damage, etc [3 months]
- Incidence rate of severe adverse events within 24 months after operation [24 months]
including but not limited to all-cause death, events requiring hospitalization or prolongation of hospitalization, severe endocarditis requiring surgery, pericarditis, cardiac perforation, valvular injury, vascular or gas embolism events, occluder detachment/displacement, occluder fracture, occluder thrombosis (DRT), stroke events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years, male or female;
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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;
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Indications for left atrial appendage closure;
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Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions;
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HAS-BLED bleeding risk score ≥ 3 points;
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Not suitable for long-term oral anticoagulant therapy;
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Poor compliance with oral anticoagulants;
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CHA2DS2-VASc score ≧ 2 points;
Exclusion Criteria:
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Valvular AF (after moderate to severe mitral stenosis or mechanical valve replacement)
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Initial AF, reversible AF with clear cause
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Presence of adherent thrombus in the left atrium or left ventricular aneurysm thrombus
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ST elevation myocardial infarction, ≤ 3 months
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Grade-IV of Cardiac Function (NYHA)
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Allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, and other anticoagulants
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Pregnant or with plan of pregnancy during the study
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Participation in another drug or medical device clinical trial or study that has not been completed
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Experience new stroke or TI within 30 days or major bleeding events within 14 days
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Contraindication to LAA closure or deemed unsuitable for study participation by the investigator
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Had a definite thromboembolic event
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
Investigators
- Principal Investigator: Chenyang Jiang, Doctor, Sir Run Run Shaw Hospital
- Principal Investigator: Jinhua Zhang, Doctor, Sir Run Run Shaw Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LAAC-01