ACTRN12610000023055已完成未知
This is a Multi-centre, Multi-country, Prospective, non-randomized, observational study to confirm the clinical safety and efficacy of the St. Jude Medical (SJM) Epic porcine valve (EPIC), which is indicated for the replacement of malfunctioning native or prosthetic aortic or mitral heart valves.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- All
入选标准
- •The patient requires replacement of the aortic and/or mitral valve
- •-The patient has signed a study specific informed consent agreeing to the data collection and follow-up requirements
- •- The patient is of legal age in host country
排除标准
- •- Patient already has a prosthetic valve, other than an aortic and/or mitral valve being replaced at this occasion
- •- Patient requries replacement of tricuspid valve or pulmonary valve
- •- The Patient is pregnant
- •- The patient has acticve endocarditis
- •- Patient is undergoing renal dialysis
- •- The patient has had an acute preoperative neurological event
- •- the paitient is an intravenous drug abuser, alcoholic or prison inmate
研究者
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