NCT01171950撤回不适用
CentriMag Ventricular Assist System (VAS): Treatment of Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Survival
研究概览
简要总结
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5 years to 16 years, inclusive
- •Inability to wean from cardiopulmonary bypass (CPB)
排除标准
- •Body weight < 20 kg
- •Severe aortic insufficiency
- •Unrestricted intra-cardiac communications (i.e. large VSD)
- •Pulmonary vascular resistance index (PVRI) > 10 IU
- •Presence of DIC
- •On hemodialysis (excluding hemofiltration)
- •Contraindications to systemic anticoagulation
- •Active systemic infection unresponsive to antibiotics
- •Unresolved malignancy
- •On other investigational VAS
结局指标
主要结局
Survival
时间窗: 30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant
In patients who recover and do not go on to transplantation or a long-term device: • Survival 30 days after removal of the CentriMag VAS or to discharge, whichever is longer. In patients who do not recover: • Ability to be removed from the CentriMag VAS and survive to induction of anesthesia for implantation of a long-term device or heart transplantation.
次要结局
- Evaluation of end-organ function(30 days after device removal, or, to induction of anesthesia for implant of a long-term device or heart transplant)
研究者
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