FAST (Fluid Accumulation Status Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 30
- 主要终点
- Number of Subjects With at Least 30 Days of Daily Impedance Measurements
研究概览
简要总结
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using very low electrical pulses that travel across the inside of the chest cavity, thoracic fluid status monitoring (OptiVol™) can measure the level of resistance to the electrical pulses, which indicates the level of fluid in the chest. The purpose of this study is to collect information related to fluid build up in the chest of subjects with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, 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
- •Subjects with one of the following implantable cardioverter defibrillators (ICDs): InSync Marquis™, InSync II Marquis™, Marquis® DR, or InSync III Marquis™.
- •Subjects with an ICD placed in the upper part of the left or right side of their chest.
- •Subjects with a lead (flexible wire that sends electrical signals from the ICD directly to the heart tissue) that is inserted through a vein and placed in the right ventricle (RV) of the heart (a transvenous RV lead).
- •Subjects who underwent the ICD implant procedure, or any readjusting of the ICD, 30 days or more prior to enrolling in the study.
排除标准
- •Subjects who are already enrolled in another clinical study.
- •Subjects who have received a heart transplant.
- •Subjects who are unable or unwilling to follow the study schedule of visits.
结局指标
主要结局
Number of Subjects With at Least 30 Days of Daily Impedance Measurements
时间窗: Up to 36 months.
Impedance measurements were presented graphically over time in relation to clinical events for all subjects with at least 30 days of follow-up and impedance data collected during the follow-up period.
次要结局
- Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF(3 days pre-admission and 3 days post-discharge)
- Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF(1 day pre and 1 day post-outpatient visit)
- Number of Adverse Events(From enrollment to study exit (up to 36 months).)