Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,744
- 试验地点
- 1
- 主要终点
- Number of Subjects with Acute Device-Related Complications
研究概览
简要总结
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).
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 compare Aveir VR LP safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population.
The study will enroll all Medicare patients implanted with the Aveir VR LP and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.
- •Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date
排除标准
- 未提供
结局指标
主要结局
Number of Subjects with Acute Device-Related Complications
时间窗: 30 days
Rate of acute complications in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker. Acute complications are defined as a peri-procedural, device-related adverse event within 30 days post-implant.
Number of Subjects Alive after 2 Years
时间窗: 2 years
The 2-year survival rate of subjects implanted with an Aveir VR LP compared with subjects implanted with single-chamber ventricular transvenous pacemaker.
次要结局
- Number of Subjects with Chronic Device-Related Complications(6 months)
- Number of Subjects with a Device-Related Re-Intervention(2 years)