Reveal LINQ™ In-Office 2 (RIO 2) Study United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 525
- 试验地点
- 30
- 主要终点
- Untoward Event Rate Associated With LINQ™ Insertions Performed
研究概览
简要总结
The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™ insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure performed in the in-office setting is as safe as LINQ™ insertions performed in the traditional hospital setting (operating room, cardiac catheterization or electrophysiology (EP) laboratory).
详细描述
RIO 2 is a two arm, randomized, prospective, un-blinded, multicenter, non-significant risk study. The primary objective for RIO 2 will be assessed by randomizing subjects to receive their LINQ™ insertion in the office setting or in the traditional hospital environment. Moving the LINQ™ insertion procedure to the office setting is not expected to decrease the complication rate compared to in hospital insertion procedures, however, moving the LINQ™ insertion procedure out of the traditional hospital setting may benefit the patient and reduce the burden to the healthcare system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
The site of the Reveal LINQ insertion was randomized. Therefore it was not possible to blind the subject or the investigator.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is indicated for continuous arrhythmia monitoring with a Reveal LINQ™ Insertable Cardiac Monitor
- •Patient is 18 years of age or older
- •Patient is willing to undergo ICM insertion procedure outside of the cath lab, OR, EP lab setting with only local anesthetic
- •Patient is willing and able to provide consent and authorize the use and disclosure of health information
- •Patient is willing and able to comply with the protocol including the required follow-up
排除标准
- •Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure
- •Patient has reduced immune function or is otherwise at high risk for infection per physician discretion
- •Current therapy with immunosuppressive agents or chronic steroid use e.g. Prednisone greater than 20mg per day
- •Patient requires hemodialysis
- •Patient with active malignancy or history of chemotherapy or radiation treatment Patient has had a recent (within 30 days) or an active infection including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia.
- •Patient has had major surgery (in the past 6 months)
- •Patient has undergone a procedure which required central venous or intraarterial access (e.g. AF/VT ablation, EP study, coronary angio) within the last 3 months or is scheduled for such a procedure while enrolled in the study.
- •Prior history of surgical infection, prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months.
- •Patient has a central venous port, an atrio-venous fistula, or a prosthetic valve
- •Patient requires conscious or moderate sedation to receive LINQ™
- •Patient is already implanted with a loop recorder
- •Patient is implanted or indicated for implant with a pacemaker, ICD, CRT device
- •Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
- •Patient's life expectancy is less than 6 months
- •Patient is pregnant
结局指标
主要结局
Untoward Event Rate Associated With LINQ™ Insertions Performed
时间窗: 3 Months post insertion
Demonstrate that the untoward event rate associated with Reveal LINQ™ insertions performed in-office or in the traditional hospital setting (operating room, cardiac catheterization or EP laboratory) are comparable. Untoward events are a composite of unsuccessful Reveal LINQ™ or complications related to the Reveal LINQ™ insertion procedure or system.
次要结局
未报告次要终点