Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,805
- 试验地点
- 2
- 主要终点
- Number of Subjects Free from Chronic Aveir DR 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 dual-chamber Aveir DR 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 DR leadless pacemaker safety in a large patient population. The results from this study will provide long-term safety data for the Aveir dual chamber LP and the Aveir atrial LP to fulfill the Condition of Approval requirements for the Aveir DR device from FDA.
Due to the RWE data collection methods used in this study, a central IRB approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.
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 DR 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 Chronic Aveir DR System-Related Complications
时间窗: 5 Years
Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure
Number of Subjects Free from Acute Aveir DR System-Related Complications
时间窗: 30 Days
Freedom from key acute complications through 30 days post implant procedure
次要结局
- Number of Subjects with End of Device Service Events(5 Years)
- Number of Subjects Free from Individual Aveir DR Leadless Pacemaker-Related(5 Years)