Aveir Single-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,427
- 试验地点
- 2
- 主要终点
- Number of Subjects Free from Acute Aveir VR System-Related Complications
研究概览
简要总结
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
详细描述
This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir VR leadless pacemaker safety in a large patient population. The results from this study will data to fulfill the Condition of Approval requirements for the Aveir VR device from FDA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Eligibility Criteria:
- •Implanted with an Aveir VR leadless pacemaker
- •Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for 30 days after implant, except in the case of death within the 30-day period
- •Ability to link with Medicare fee-for-service data
排除标准
- 未提供
结局指标
主要结局
Number of Subjects Free from Acute Aveir VR System-Related Complications
时间窗: 30 days
Freedom from complications through 30 days post implant procedure
Number of Subjects Free from Chronic Aveir VR System-Related Complications
时间窗: 10 Years
Freedom from Complications from 31 days through 10 years post implant procedure procedure
次要结局
- Number of Subjects with End of Device Service Events(10 Years)
- Number of Subjects Free from Individual Aveir VR Leadless Pacemaker-Related Complications(10 Years)