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The prognostic implication of left atrial appendage occlusion (LAAO) procedure in non-valvular atrial fibrillation (NVAF) patients from China is still unclear. We aim to investigate the impact of LAAO procedure on subsequent clinical outcomes in patients from China.
Although the left atrial appendage occlusion (LAAO) procedure has increasingly been performed to prevent the occurrence of ischemic stroke events among patients with non-valvular atrial fibrillation (NVAF), the clinical benefits and prognostic implications of which have not been well characterized in patients from China. As a result, we aim to conduct an observational study to explore the prognostic impact of LAAO in patient with NVAF who are hospitalized in Shanghai Tenth People's Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left atrial appendage occlusion | Patients with non-valvular atrial fibrillation who have received left atrial appendage occlusion procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| left atrial appendage occlusion devices | Device | All NVAF patients who are admitted for receiving left atrial appendage occlusion procedure, including Watchman, LAmbre, Lefort, and Leftear deveices. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular and cerebral events (MACCE) | A composite of all-cause death, ischemic stroke, heart failure rehospitalization and major bleeding events | From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | Death from any cause | From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years |
| Cardiovascular death | Death from cardiovascular causes |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with NVAF who are referred for LAAO procedure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengmeng Gong, M.D. | Contact | +86-188-0179-0469 | zoemodi@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Yawei Xu, M.D., Ph.D. | Department of Cardiology, Shanghai Tenth People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Shanghai Tenth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200072 | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years |
| Ischemic stroke | Ischemic stroke is defined as the presence of a new focal neurologic deficit thought to be ischemia in origin, with signs or symptoms lasting>24h | From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years |
| Major bleeding | The incidence of major bleeding as defined by BARC (3-5) | From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years |
| Heart failure rehospitalization | Rehospitalization for heart failure | From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years |
| Pericardial effusion | Pericardial effusion validated by echocardiography | From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |