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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 LAmbreâ„¢ 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 LAmbreâ„¢ 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.
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| 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 |
| 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 |
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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:
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:
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Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Xia | Contact | +86 13760184511 | xiaying@lifetechmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Congxin Huang | People's Hospital of Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical university | Beijing | Beijing Municipality | China | |||
| Fuwai Hospital Chinese Academy of Medical Science |
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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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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 |
| Beijing |
| Beijing Municipality |
| China |
|
| The 2nd Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
|
| 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 | Shanghai | Shanghai Municipality | China |
|
| West China Hospital, Sichuan University | Chengdu | China |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |