LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct a continuous telephone follow-up study on subjects who had completed the one-year follow-up of the LAmbre™ left atrial appendage (LAA) system registration trial. The follow-up time was 2 years, 3 years, 4 years and 5 years after left atrial appendage closure operation, to evaluate the long-term safety and effectiveness of LAmbre™ LAA Closure System.

Detailed Description
-----------------
All subjects who completed 1-year follow-up of the LAmbreTM LAA system registration trial will be conducted 2 years, 3 years, 4 years and 5 years follow-up by the telephone call. During the follow-up, the investigator or his/her designee will use a standardized form to record the occurrence of the subject's safety events and validity endpoint by telephone，and complete the safety and efficacy summary report. The endpoints of the study included compound events, MACCE events, stroke, haemorrhage and other events.

Official Title
-----------------
LAmbre™ Left Atrial Appendage Closure System Post-Market 2-5 Years Follow-Up Study

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up. The inclusion criteria of LAmbreTM Safety and Efficacy Study: Age>=18, CHADS2 score>=1 Patients cannot be treated long-term with Warfarin Eligible for clopidogrel and aspirin Provide written informed consent and agree to comply with the required follow-ups Exclusion Criteria: - Exclusion criteria: Patients who did not participate in the LAmbreTM Safety and Efficacy Study or did not complete 1-year follow-up LAmbreTM Safety and Efficacy Study. The exclusion criteria of LAmbreTM Safety and Efficacy Study: Need to take Warfarin Presence of rheumatic, degenerative or congenital valvular heart diseases Early stage or paroxysmal atrial fibrillation Symptomatic patients with carotid artery disease (such as carotid stenosis>=50%) Heart failure NYHA grade IV Recent 30 days stroke or TIA Presence of active sepsis or endocarditis Cardiac tumours or other malignancy with estimated life expectancy <2 years Abnormal blood test; renal dysfunction LAA removed or heart implant patients Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system Patients have a history of mechanical prosthesis operation Patients who are pregnant, or desire to be pregnant during the during the study Participation in other trials A known allergy to nitinol Patients will not be able to complete the trial

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of compound event | The compound event including death, systemic embolization, complications related to the device and requiring treatment (cardiac embolism, embolization, stroke, hemorrhage, death). | 5 years after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of MACCE events | The MACCE events including death (All cause death, All-cause death includes cardiac death, non-cardiac death and unexplained death), stroke, cardiac tamponade, and renal failure. | 2,3,4,5 years postoperative follow-up. | 
| Ischemic stroke rate | Ischemic stroke is a neurological deficit caused by transient ischemic attack, cerebral thrombosis or cerebral embolism. | 2,3,4,5 years postoperative follow-up | 
| The rate of stroke | Stroke is deviated into ischemic, hemorrhagic or undetermined stroke, and transient ischemic attacks (TIA). | 2,3,4,5 years postoperative follow-up | 
| The event of bleeding | Intracranial or alimentary canal, or any bleeding that requires transfusion of 2 units of red blood cell suspension. | 2,3,4,5 years postoperative follow-up | 
| Cardiac events | Non-fatal myocardial infarction, arrhythmia, cardiac tamponade, cardiogenic shock, endocarditis. | 2,3,4,5 years postoperative follow-up |