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The aim of the study is to enroll approximately 200 cases from 10 research centers nationwide, completed left atrial appendage occlusion (LAAO) successfully, and give apixaban (5 mg bid) postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anticoagulant therapy after percutaneous left atrial appendage | Oral apixaban |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral apixaban | Drug | apixaban (5 mg bid) is given until 12 weeks after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse cardiovascular events | all cause death, stroke, transient ischemic attack, systemic embolism | within 24 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhagic/ischemic stroke events | Stroke was defined as patients who developed dysarthria, aphasia, or weakness or sensory loss in the contralateral face, arm, or leg and cerebral ischemia and/or infarction. Diagnosis by clinical symptoms and cranial imaging examination. | within 24 weeks after surgery |
| Bleeding event |
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Inclusion Criteria:
Exclusion Criteria:
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The study is going to enroll approximately 200 cases who completed left atrial appendage occlusion (LAAO) successfully from 10 research centers nationwide.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaochun Zhang | Contact | 15002121366 | zhang.xiaochun1@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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Including dermal, mucosal, nasal, oral, gastrointestinal bleeding |
| within 24 weeks after surgery |
| Incidence of deaths | All cause deaths (cardiac death, and non cardiac death) | witnin 24 weeks after surgery |
| Device related thrombosis | Doctors find thrombosis after LAAC by transesophageal echocardiography. | 12 weeks and 24 weeks after surgery |
| Incidence of cardiovascular disease-related rehospitalization | Cardiovascular disease include pericardial effusion, pericardial tamponade, poor cardiac function | 12 weeks and 24 weeks after surgery |
| severe adverse events | Severe adverse events include re-inpatient for poor cardiac function and other severe adverse events. | 12 weeks and 24 weeks after surgery |