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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transthoracic Echocardiography | Diagnostic Test | After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation | Ischemic stroke, systemic embolism, and cardiac death events | 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 | Bleeding events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical success rate | Surgical success | 24 months |
| 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. |
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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;
Exclusion Criteria:
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Patients with non-valvular atrial fibrillation and previous AF-related embolic events
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenyang Jiang, Doctor | Contact | 8613857190051 | panshangming@lifetechmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Chenyang Jiang, Doctor | Sir Run Run Shaw Hospital | Principal Investigator |
| Jinhua Zhang, Doctor | Sir Run Run Shaw Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250000 | China |
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| ID | Term |
|---|---|
| D000083262 | Embolic Stroke |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D017548 | Echocardiography, Transesophageal |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 3 months |
| 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 | 24 months |
| (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 | 7 days |
| Procedure-related complications during follow-up | 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 | 24 months |
| Occluder defects during operation and in the 3rd month after operation | Including but not limited: Occluder displacement, Occluder detachment, Occluder breakage, Occluder damage, etc | 3 months |
| Incidence rate of severe adverse events within 24 months after operation | 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 | 24 months |
| Shanghai Songjiang District Central Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| Sichuan Mianyang 404 Hospital | Recruiting | Mianyang | Sichuan | 621000 | China |
|
| The first Affiliated Hospital of WMU | Recruiting | Wenzhou | Zhejiang | 325600 | China |
|
| The Second Affiliated Hospital and Yuying Children's Hospital of WMU | Recruiting | Wenzhou | Zhejiang | 325600 | China |
|
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |