NCT03505801进行中（未招募）不适用
Confirm Rx Insertable Cardiac Monitor SMART Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,826
- 试验地点
- 225
- 主要终点
- Freedom from device SADEs and serious procedure related SAEs
研究概览
简要总结
The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.
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
- •Have an approved indication for continuous arrhythmia monitoring with an ICM
- •Have a cellular phone or the ability or willing to use a St. Jude Medical mobile transmitter that is compatible with the MyMerlin App and able to communicate with the Confirm Rx ICM device.
- •Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- •Are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
排除标准
- •Subject is implanted with or indicated for implant with a pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
- •Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by the sponsor, during the course of this clinical study.
- •Have a life expectancy of less than 1 year due to any condition.
- •Have a previous ICM placement.
结局指标
主要结局
Freedom from device SADEs and serious procedure related SAEs
时间窗: 1 month post insertion procedure
次要结局
- Freedom from device SADEs and serious procedure related SAEs(12 months post insertion procedure)
- R wave amplitude(12 months post insertion procedure)
研究者
研究点 (225)
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