NL-OMON43837已完成不适用
International long-term follow-up study of patients implanted with a PORTICO* valve - Portico I
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
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
- •1. Patient has signed the Patient Informed Consent prior to participating in the clinical investigation.
- •2. Patient has been referred for a Portico Valve implant as per Heart Team decision.
- •3. Patient has senile degenerative aortic valve stenosis confirmed by echocardiographically derived criteria
- •4. Patient has a life expectancy of more than (>) 12 months.
排除标准
- •1. Any case in which the Portico Valve would not be indicated for the patient as per current IFU (i.e. any *off-label* use).
- •2. Patient has any other aortic valve than tricuspid one.
- •3. Patient has a prosthetic valve or ring in the aortic position.
- •4. Patient needs a concomitant structural heart procedure.
- •5. Patient is unwilling or unable to comply with all clinical investigation-required follow-up evaluations.
- •6. Patient is pregnant
研究者
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