NCT00291551终止1 期
Paracor Ventricular Support System: United States Clinical Investigational Plan
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 24
- 主要终点
- Death or Additional Surgical Session at 6 Months
研究概览
简要总结
This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor Ventricular Support System when used to treat patients with heart failure. The implant, which is loaded onto the delivery system, is placed over the epicardial surface of the right and left ventricles.
No formal hypothesis testing will be performed; descriptive statistics will be used to summarize patient outcomes. The results of the study will be used to guide the design and sample size estimation of future studies.
详细描述
Please refer to brief summary.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NYHA functional class II or III
- •Best medical therapy
- •Ejection fraction <= 35%
排除标准
- •Heart measurements too large or small for implant sizes
- •Intra-cardiac thrombus
- •Restrictive cardiomyopathy
- •Not a candidate for sternotomy
- •Expected adhesions
- •Previous coronary artery bypass graft (CABG)
- •Active infection
- •Stroke, surgery, or implantable cardioverter defibrillator (ICD) within 3 months
- •Myocardial infarction (MI) within 1 month
结局指标
主要结局
Death or Additional Surgical Session at 6 Months
时间窗: 6 months
次要结局
- Implant Success (Number of Participants Successfully Implanted)(1 day)
- Change in NYHA Functional Class(Baseline to 6 months)
- Changes in Left Ventricular Diameters(Baseline to 6 months)
- Changes in Left Ventricular Volumes(Baseline to 6 months)
- Change in Left Ventricular Ejection Fraction(Baseline to 6 months)
- Change in Left Ventricular Mass(Baseline to 6 months)
- Changes in 6 Minute Walk(Baseline to 6 months)
- Changes in Cardiopulmonary Tests(Baseline to 6 months)
- Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score(Baseline to 6 months)
- Number of Adverse Events(Study duration)
- Number of Participants Who Died(Study duration)
研究者
研究点 (24)
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