Use of Bioelectrical Impedance Analysis in the Nutritional Assessment of Patients With CHF Equipped With Implantable Cardioverter Defibrillators
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of patients who have electromagnetic interference of the ICD when exposed to BIA.
研究概览
简要总结
Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA) and implantable cardioverter defibrillators (ICDs).
详细描述
Electrograms of ICDs will be analyzed during wireless telemetry and during body composition measurement using BIA. ICD therapy will have been temporarily inactivated before the measurement to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. Body composition will be measured at three frequencies (5 khz, 50 khz and 100 khz).
Interference will be assessed by the presence of visible artefacts on the real-time electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes. The outcome measure will be the number and proportion of patients who have electromagnetic interferences of the ICD when BIA is done.
The procedure will take approximately 5-10minutes, with reprogramming of the device at the end of the test. No further follow-up in the context of the study will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Implantation with a wireless-enabled ICD
排除标准
- •Age <18yrs
- •Inability to sign an informed consent
- •Pacemaker dependancy
结局指标
主要结局
Number of patients who have electromagnetic interference of the ICD when exposed to BIA.
时间窗: 5-10 minutes
次要结局
未报告次要终点
研究者
Philippe Meyer
MD
University Hospital, Geneva