Harmony Transcatheter Pulmonary Valve Use-Results Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 主要终点
- Proportion of patients with favorable hemodynamic function without valve reintervention
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
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •The Product is for use in patients with severe pulmonary regurgitation who have previously undergone surgical repair or transcatheter intervention (balloon valvuloplasty) to the right ventricular outflow tract, and are in clinical need of a pulmonary valve replacement. However, it is intended for use in patients for whom surgical procedures pose a high risk, and for whom the Product is deemed to be the optimal treatment. Note that this product should not be used for patients who have an artificial valve or a right ventricle to pulmonary artery conduit implanted.
排除标准
- 未提供
结局指标
主要结局
Proportion of patients with favorable hemodynamic function without valve reintervention
时间窗: 1 year after the initial procedure
Proportion of patients with favorable hemodynamic function without valve reintervention at 1 year after the initial procedure
Procedure success rate
时间窗: 30 days after the initial procedure
Procedure success rate at 30 days after the initial procedure
Device success rate
时间窗: up to 5 years after the initial procedure
Device success rate up to 5 years after the initial procedure
RVOT re-operation rate attributable to the Product
时间窗: up to 5 years after the initial procedure
RVOT re-operation rate attributable to the Product up to 5 years after the initial procedure
Re-interventation rate for the product
时间窗: up to 5 years after the initial procedure
Re-interventation rate for the product up to 5 years after the initial procedure
Incidence of valve dysfunction
时间窗: up to 5 years after the initial procedure
Incidence of valve dysfunction up to 5 years after the initial procedure
Death due to any cause
时间窗: up to 5 years after the initial procedure
Death due to any cause up to 5 years after the initial procedure
Adverse events and defects for which a causal relationship with the procedure or the Product cannot be ruled out
时间窗: up to 5 years after the initial procedure
Adverse events and defects for which a causal relationship with the procedure or the Product cannot be ruled out (up to 5 years after the initial procedure)
次要结局
未报告次要终点