LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

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追踪信息

首次提交日期 ^ICMJE

September 30, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

November 20, 2018

预计主要完成日期

April 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

The incidence of compound event[ Time Frame: 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).

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

The incidence of MACCE events[ Time Frame: 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.
Ischemic stroke rate[ Time Frame: 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 rate of stroke[ Time Frame: 2,3,4,5 years postoperative follow-up ]
Stroke is deviated into ischemic, hemorrhagic or undetermined stroke, and transient ischemic attacks (TIA).
The event of bleeding[ Time Frame: 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[ Time Frame: 2,3,4,5 years postoperative follow-up ]
Non-fatal myocardial infarction, arrhythmia, cardiac tamponade, cardiogenic shock, endocarditis.

描述性信息

简略标题 ^ICMJE

LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

正式标题 ^ICMJE

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

简要概况

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.

详细说明

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.

研究类型 ^ICMJE

Observational [Patient Registry]

研究阶段

研究设计 ^ICMJE

分配:
干预模型:
干预模型描述:
盲法: Observational [Patient Registry]
盲法描述:
主要目的:

适用条件 ^ICMJE

干预项目 ^ICMJE

研究工具

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

156

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

July 2020

预计主要完成日期

April 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

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: 1. Age>=18, CHADS2 score>=1 2. Patients cannot be treated long-term with Warfarin 3. Eligible for clopidogrel and aspirin 4. 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: 1. Need to take Warfarin 2. Presence of rheumatic, degenerative or congenital valvular heart diseases 3. Early stage or paroxysmal atrial fibrillation 4. Symptomatic patients with carotid artery disease (such as carotid stenosis>=50%) 5. Heart failure NYHA grade IV 6. Recent 30 days stroke or TIA 7. Presence of active sepsis or endocarditis 8. Cardiac tumours or other malignancy with estimated life expectancy <2 years 9. Abnormal blood test; renal dysfunction 10. LAA removed or heart implant patients 11. Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system 12. Patients have a history of mechanical prosthesis operation 13. Patients who are pregnant, or desire to be pregnant during the during the study 14. Participation in other trials 15. A known allergy to nitinol 16. Patients will not be able to complete the trial

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

China

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Lifetech Scientific (Shenzhen) Co., Ltd.

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Congxin Huang People's Hospital of Wuhan University

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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