NL-OMON44486已完成不适用
CGA-TAVI Registy - CGA-TAVI Registy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •All Patients scheduled for transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve in participating sites.
- •Compliance with the indications of the instructions for use (Appendices 12.1 / 12.2):
- •- symptomatic severe calcific aortic stenosis requiring aortic valve replacement
- •- estimated operative/procedural mortality risk * 15% as assessed by a risk tool such as the Logistic EUROSCORE or STS-PROM
- •Age of at least 80 years
- •Written informed consent
排除标准
- •Presence of contraindications as to the Instructions for Use
- •No possibility for a follow-up
研究者
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