NL-OMON37262已完成不适用
Determining Accuracy and Trending Characterization of AF - DETECT AF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
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
- •- The subject has been implanted with a SJM Confirm ICM, DM2102.
- •- The subject has or is suspected to have paroxysmal AF.
- •- The subject is * 18 years of age.
- •- The subject is willing and able to provide written Informed Consent (prior to any
- •investigational related procedure).
排除标准
- •- The subject has persistent (>7 days and <1 year or AF requiring cardioversion),
- •longstanding persistent (continuous AF >1 year) or permanent AF (not attempting to
- •restore sinus rhythm).
- •- The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
- •- The subject has a contraindication to Holter recording.
- •- The subject has already received an active implantable medical device other than the
- •SJM Confirm ICM, DM2102.
- •- The subject is unable to comply with the follow up schedule.
- •- The subject is participating in another investigational device or drug investigation.
- •- The subject is pregnant or is planning to become pregnant during the duration of the
- •investigation.
研究者
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