NL-OMON48966已完成不适用
Confirm RxTM Insertable Cardiac Monitor SMART Registry - SMART Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
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 RxTM ICM device. If a subject doesn*t have a cell
- •phone or loses their cell phone, then the site can provide a St. Jude Medical
- •mobile transmitter to the subject. The study will not provide cell phones.
- •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.
研究者
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