DEtermining Accuracy and TrEnding CharacTerization of AF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 13
- 主要终点
- Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.
研究概览
简要总结
The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).
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
- •The subject has been implanted with a SJM Confirm ICM, DM
- •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 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, DM
- •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.
结局指标
主要结局
Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.
时间窗: 4 days after Holter starts
Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM. Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.
次要结局
未报告次要终点