Medtronic Reveal LINQ Insertable Cardiac Monitor Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,604
- 试验地点
- 48
- 主要终点
- Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature
研究概览
简要总结
The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.
详细描述
The study is a prospective, non-randomized, observational, multi-center, global study. The study will characterize clinical actions initiated by Reveal LINQ arrhythmia detection and estimate procedure-related acute infection rate. Approximately 1,500 subjects will be implanted with a Reveal LINQ ICM and undergo continuous remote monitoring and be followed prospectively from insertion through 36 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
- •Subject is intended to receive or be treated with the have a Reveal LINQ ICM inserted in the next 30 days.
- •Patient enrolled before or on the same date of insertion of the Reveal LINQ ICM
- •Subject consent prior to ICM insertion
排除标准
- •Subject who is, or is expected to be inaccessible for follow-up
- •Subject with exclusion criteria required by local law
- •Subject is currently enrolled in or plans to enroll a concurrent study that may confound the results of this study. Co-enrollment in any concurrent drug and/or device clinical study (including registries) requires approval of the study manager or designee.
结局指标
主要结局
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature
时间窗: Implant to 36 months post-implant
Clinical actions taken over the course of study follow-up
Number of Participants With Procedure-related Acute Infection Rate
时间窗: Implant to 30 days post-implant
Acute infection rate in the subjects who were followed for at least 30 days or had an infection prior to 30 days. Infections are as assessed by the Investigator and defined as deep incision site or superficial infection. Deep incision site are classified as pain, redness, or drainage at incision site requiring the device to be removed or IV antibiotics administered. Superficial infections are defined as redness beyond procedure expectation and oral antibiotics administered. For both deep incision and superficial infections, a physician directed intervention must occur for the event to be defined as an infection.
次要结局
未报告次要终点