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临床试验/NCT03338946
NCT03338946已完成不适用

Evaluation of Cardiac Implanted Electronic Devices (CIED) "Readers" for Hospital Disease Management

Edward Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope

研究概览

简要总结

The purpose of this study is to evaluate the use of remote interrogation (readers) of CIEDs in evaluation of suspected TIA/stroke patients, HF or those experiencing syncope. This approach has the potential to advance the practice of CIED evaluation by staff without specialized training in cardiac electrophysiology (non-EP staff). We hypothesize that actionable events will be identified with use of CIED readers. These events may include identification of atrial fibrillation in TIA/stroke patients, percentage biventricular pacing in patients with HF or evaluation of arrhythmic events in syncope patients. We believe that non-EP staff will find CIED readers easy or very easy to use and that time from transmission to analysis for non-EP trained staff will be low.

详细描述

Subjects with CIEDs undergoing evaluation for TIA/stroke, HF or syncope will be reviewed for inclusion/exclusion criteria. CIED interrogation, demographics and time of interrogation will be collected. Review of interrogation and medical record will be done to evaluate for actionable events including CIED programming, initiation or change in medications, admission/discharge or decision for further testing.

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

入选标准

  • have a Medtronic CIED compatible with Medtronic CareLink Express
  • being evaluated for heart failure, TIA/stroke or syncope
  • able to read and speak English

排除标准

  • CIED from other than Medtronic

结局指标

主要结局

Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope

时间窗: one day

percent of those with events after reader review with actions such as admission/discharge, addition or change in medications, further testing

次要结局

  • Average number of minutes from transmission to analysis(one day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Janet Gifford

Nurse Practitioner

Edward Hospital

研究点 (1)

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