NL-OMON38837撤回不适用
REVEAL for Respiration Detection (REST) - REST
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 15
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
- •Subject is implanted with a Reveal ICM or Reveal XT ICM for unexplained syncope or suspected arrhythmia
- •Subject (or the legal representative) is willing to sign informed consent form
- •Subject is 18 years or older
排除标准
- •Significant respiratory diseases such as COPD or pulmonary hypertension.
- •Patients with frequent arrhythmias, including PVC*s.
- •Patients with known heart failure.
- •Body conditions that would complicate accurate measurement of respiratory rate with the MediByte device
- •Patients which are not able to take the postures as necessary for the study protocol and which cannot walk continuously for a period of 6 minutes
- •Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
- •Subject is enrolled in one or more concurrent studies that would confound the results of this study
研究者
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