LAmbre™ Left Atrial Appendage Closure System Post-Market 2-5 Years Follow-Up Study
试验速览
- 阶段
- 不适用
- 入组人数
- 156
- 试验地点
- 11
- 主要终点
- The incidence of compound event
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The incidence of compound event
时间窗: 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).
次要结局
- The incidence of MACCE events(2,3,4,5 years postoperative follow-up.)
- The rate of stroke(2,3,4,5 years postoperative follow-up)
- Ischemic stroke rate(2,3,4,5 years postoperative follow-up)
- The event of bleeding(2,3,4,5 years postoperative follow-up)
- Cardiac events(2,3,4,5 years postoperative follow-up)