Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Prognostic Implications of Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation at Shanghai Tenth People's Hospital

Conditions
-----------------
Atrial Fibrillation, Left Atrial Appendage Occlusion

Intervention / Treatment
-----------------
* Device: left atrial appendage occlusion devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were admitted for NVAF undergoing LAAO procedure between January 2014 and December 2017 in the Cardiology Department of Shanghai Tenth People's Hospital; Adult patients (>18 years old). Exclusion Criteria: Patients with rheumatic valvular disease; Patients with sick sinus syndrome; Patients who had a history of cardiac surgery (i.e., CABG); patients who had received the catheter radiofrequency ablation procedure.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Left atrial appendage occlusion<br>Patients with non-valvular atrial fibrillation who have received left atrial appendage occlusion procedure. | Device: left atrial appendage occlusion devices<br>* All NVAF patients who are admitted for receiving left atrial appendage occlusion procedure, including Watchman, LAmbre, Lefort, and Leftear deveices.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation; left atrial appendage occlusion