NL-OMON39322尚未招募不适用
Assessing standard oF care and clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, active, pOst-market surveillaNce study. - FOUNDATIO
Edwards Lifesciences SA0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject is 18 years or older
- •2. Subject presents with aortic stenosis or stenosis-based insufficiency of an aortic valve requiring a planned replacement of the native aortic valve or previously implanted aortic prosthesis.
- •3. Subject has signed and dated the investigation informed consent forms prior to study-specific procedures are performed.
- •4. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.
排除标准
- •1. History of active endocarditis within three months of scheduled surgery
- •2. Subject is diagnosed with pure aortic insufficiency
- •3. Aneurysm of the aortic root and/or ascending aorta
研究者
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