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.
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.
Study Type
OBSERVATIONAL
Enrollment
156
Beijing Chaoyang Hospital, Capital Medical university
Beijing, Beijing Municipality, China
Fuwai Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
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).
Time frame: 5 years after the surgery
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 2,3,4,5 years postoperative follow-up
Cardiac events
Non-fatal myocardial infarction, arrhythmia, cardiac tamponade, cardiogenic shock, endocarditis.
Time frame: 2,3,4,5 years postoperative follow-up
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People's Hospital of Wuhan University
Wuhan, Hubei, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Shandong, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated Shanghai Jiaotong University School of Medicine
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...and 1 more locations