NCT01170624终止4 期
Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- LivaNova
- 入组人数
- 388
- 试验地点
- 50
- 主要终点
- The objective is to demonstrate that agreement correlation is superior to 67%
研究概览
简要总结
The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general ICD population.
详细描述
The study will particularly focus on a new sensor-based diagnostic feature, called PhD-Clinical Status (PhD). A dedicated PhD screen shows the trends of patients' ventilation levels at rest (MVR) and under effort (MVE), and the corresponding level of activity, day-by-day, over a period of 6 months.
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
- None
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
- •Patient eligible for implantation of an ICD or a CRT-D device according to current available guidelines.
- •Documented chronic HF (NYHA Class II to IV) at the time of enrollment
- •Scheduled for implant of a PARADYM ICD / CRT-D or implanted within the previous month
- •Signed and dated informed consent
排除标准
- •Any contraindication for ICD therapy
- •Abdominal implantation site
- •Acute myocarditis
- •Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
- •Planned heart transplant
- •Mechanical tricuspid valve
- •Unable to perform the 6 minute Walking Test at time of enrollment
- •Already included in another clinical study
- •Life expectancy less than 13 months
- •Inability to understand the purpose of the study or refusal to cooperate
- •Inability or refusal to provide informed consent
- •Under guardianship
- •Age of less than 18 years
- •Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)
结局指标
主要结局
The objective is to demonstrate that agreement correlation is superior to 67%
时间窗: 13 months
次要结局
未报告次要终点
研究者
研究点 (50)
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