NCT00916929已完成不适用
Detect Fluid Early From Intra-thoracic Impedance Monitoring
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 67
- 主要终点
- False Positive Rate
研究概览
简要总结
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days
- •Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months
排除标准
- •History of kidney disease requiring hemodialysis
- •Refractory end stage heart failure
研究组 & 干预措施
Implantable Cardioverter Defibrillator (ICD)
Other
Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD).
干预措施: Impedance Monitoring Feature (Device)
Cardiac Resynchronization Therapy (CRT-D)
Other
Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.
干预措施: Impedance Monitoring Feature (Device)
结局指标
主要结局
False Positive Rate
时间窗: 6-months
False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.
次要结局
- Sensitivity(6-months)
研究者
研究点 (67)
Loading locations...
相似试验
已完成
不适用
Dynamic Thoracic Impedance as a Marker for Heart Failure DecompensationHeart Failure With DecompensationNCT02134379Charles Porter, MD11
已完成
不适用
Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring SystemFluid Retention TissueNCT03072732Zoll Medical Corporation40
招募中
不适用
A Portable Thoracic Impedance Device for Detecting Pulmonary Congestion in Heart Failure PatientsHeart FailureNCT06604468Centre hospitalier de l'Université de Montréal (CHUM)30
招募中
不适用
Non-Invasive Measurements of Changes in Pulmonary Artery Pressure in Intensive Care Unit Patients Using Electrical Impedance Tomography - A Feasibility StudyPulmonary Artery HypertensionNCT06544148Insel Gruppe AG, University Hospital Bern28
已完成
不适用
Cardiac Resynchronization Therapy Defibrillator Based Impedance Monitoring StudyHeart FailureNCT00500838Abbott Medical Devices75