Amplatzer™Amulet™ Observational Post-Market Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,088
- 试验地点
- 51
- 主要终点
- Number of Participants With Acute Serious Adverse Events
研究概览
简要总结
This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."
详细描述
A total of 1088 subjects were enrolled in the study at 61 sites internationally, outside the United States.
The study assessed acute and late serious adverse events and reports the rate of stroke and bleeding events through 2 years. No formal hypothesis were tested for this observational post-market study.
Each patient was followed at study visits at baseline, implant, 1-3 months, 6 months, 12 months, and 24 months post implant."
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Subject with history of paroxysmal, persistent or permanent NVAF
- •Subject who is 18 years or older, or of legal age to give informed consent specific to state and national law
- •Subject who is eligible for an Amulet LAA Occluder device according to current international guidelines and per physician discretion
- •Subject who is willing and capable of providing informed consent, participating in all associated study activities
排除标准
- •Subject with evidence of an intracardiac thrombus
- •Subject with active infection or active endocarditis or other infections producing bacteremia
- •Subject where the placement of the device would interfere with any intracardiac or intravascular structures
- •Subject with any medical disorder that would interfere with completion or evaluation of clinical study results
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
- •Subject with LAA anatomy that does not accommodate a device per the sizing guidelines
结局指标
主要结局
Number of Participants With Acute Serious Adverse Events
时间窗: 0 to 7 days post procedure
Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure
Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure
时间窗: 7 days through 2 years
Late adverse events were defined as those serious events with an onset date \> 7 days post-procedure
Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death
时间窗: Implant through 2 years
Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years
Number of Participants With Major Bleeding Events
时间窗: Implant through 2 years
Clinical events were adjudicated by the CEC as major bleeding events if they met the definition of Type 3 or greater on the Bleeding Academic Research Consortium (BARC) scale.
次要结局
- Number of Participants With Procedural Success(During the implant procedure and hospital stay, approximately 1 or 2 days)
- Number of Participants With Oral Anti-coagulation Usage(At 24 months)
- Number of Participants With Technical Success(During implant procedure, approximately 30 to 60 minutes)