LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
The incidence of compound event	5 years after the surgery	The compound event including death, systemic embolization, complications related to the device and requiring treatment (cardiac embolism, embolization, stroke, hemorrhage, death).

Secondary Outcome Measures

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

Locations (11): Beijing Chaoyang Hospital, Capital Medical university
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Beijing, Beijing, China
Fuwai Hospital Chinese Academy of Medical Science
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Beijing, Beijing, China
The General Hospital of Shenyang Military Region
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Shenyang, Liaoning, China
The 2nd Affiliated Hospital of Harbin Medical University
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Harbin, Heilongjiang, China
Jiangsu Province Hospital
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Nanjing, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University
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Dalian, Shandong, China
West China Hospital, Sichuan University
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Chengdu, China
People's Hospital of Wuhan University
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Wuhan, Hubei, China
Shanghai Tenth People's Hospital
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Shanghai, Shanghai, China
Xinhua Hospital Affiliated Shanghai Jiaotong University School of Medicine
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Shanghai, Shanghai, China
Wuhan Asia Heart Hospital
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Wuhan, Hubei, China