Reveal LINQ™ In-Office 2 (RIO2) International Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 191
- 主要终点
- Number of Participants With Untoward Events
研究概览
简要总结
The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".
详细描述
The traditional location of the LINQ™ insertion procedure is the catheterization laboratory, electrophysiology laboratory, or operating room. The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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 (ICM)
- •Patient is at least 18 years of age or older if required by local regulations
- •Patient is willing to undergo ICM insertion procedure outside of the cathlab, operating room, 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 elements of the clinical investigation plan including the required follow-up
排除标准
- •Patient has unusual thoracic anatomy or scarring at the insertion site which may adversely affect the success of the insertion 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 intra-arterial access (e.g. AF/VT ablation, EP study, coronary angiography) 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 already has an inserted or implanted 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 legally incapable of giving consent
- •Patient is pregnant* *Note: Possible pregnancy will be assessed by the physician asking the patient; a pregnancy test is not required
研究组 & 干预措施
Out of CathLab setting
Out of cathlab insertion
干预措施: Out of cathlab insertion (Other)
结局指标
主要结局
Number of Participants With Untoward Events
时间窗: 3 months
An untoward event is a composite endpoint defined as a LINQTM or LINQTM insertion procedure related complication OR an unsuccessful LINQTM insertion procedure, where a LINQTM or LINQTM insertion procedure related complication is defined as an adverse event related to the LINQTM or a LINQTM insertion procedure resulting in: * Death * Termination of significant device function * Invasive intervention (e.g. includes LINQTM revision/explant for reasons other than diagnosis of underlying condition, intravenous drug administration)
次要结局
未报告次要终点