Embolic Stroke, Non-valvular Atrial Fibrillation
Conditions
Keywords
AF-related embolic events, non-valvular atrial fibrillation, Left Atrial Appendage Closure
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.
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).
Interventions
DIAGNOSTIC_TESTTransthoracic Echocardiography
After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.
Sponsors
Lifetech Scientific (Shenzhen) Co., Ltd.
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; 1. HAS-BLED bleeding risk score ≥ 3 points; 2. Not suitable for long-term oral anticoagulant therapy; 3. Poor compliance with oral anticoagulants; 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation | 12 months | Ischemic stroke, systemic embolism, and cardiac death events |
| 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 | Bleeding events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Ischemic stroke, systemic embolism, and cardiac death events |
| (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 |
| Surgical success rate | 24 months | Surgical success |
| Occluder defects during operation and in the 3rd month after operation | 3 months | Including but not limited: Occluder displacement, Occluder detachment, Occluder breakage, Occluder damage, etc |
| 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 |
| 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 |
| 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. |
Countries
China
Contacts
Primary ContactChenyang Jiang, Doctor
Outcome results
None listed