NCT01956578Unknown不适用
REVEAL for Respiration Detection
Medtronic BRC2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Respiration rate derived from the Reveal ICM ECG correlated with the respiration rate from the external respiratory band during a three minute period of normal breathing.
研究概览
简要总结
This study will evaluate the correlation between the respiratory rate derived from the Reveal Insertable Cardiac Monitor (ICM) electrocardiogram (ECG) with the respiratory rate obtained from an external respiratory band in patients previously implanted with a Reveal for unexplained syncope or suspected arrhythmia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •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 or as specified minimal age per local law/regulation
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 respiration 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
结局指标
主要结局
Respiration rate derived from the Reveal ICM ECG correlated with the respiration rate from the external respiratory band during a three minute period of normal breathing.
时间窗: Up to 3 minutes
次要结局
- Respiration rate obtained from the REVEAL ICM ECG with the respiratory rate obtained from external respiratory band during three minute periods of periodic, controlled breathing and elevated heart rate.(Up to 3 minutes)
研究者
研究点 (2)
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