NCT00614510已完成不适用
The SynCardia CardioWest Temporary Total Artificial Heart (TAH-t) Postmarket Surveillance Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 主要终点
- Subject survival at 30-days and one-year post transplant
研究概览
简要总结
The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training defined in the SynCardia Systems, Inc. Training Manual and who enroll subjects who meet the intended use defined in the product Instructions for Use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The TAH-t is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
排除标准
- •Patients who are not cardiac transplant eligible.
- •Patients who do not have sufficient space in the chest area vacated by the natural ventricles. Generally this includes patients who have body surface areas <1.7m², or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) < 10 cm.
- •Patients who cannot be adequately anticoagulated on the TAH-t.
结局指标
主要结局
Subject survival at 30-days and one-year post transplant
时间窗: 30-days and one-year post transplant
次要结局
未报告次要终点
研究者
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