Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 24
- 主要终点
- Acute Device Success
研究概览
简要总结
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
详细描述
This is a single arm, prospective, multicenter post-approval study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Native or surgically-repaired RVOT with severe PR
- •Clinically indicated for pulmonary valve replacement
- •Planned for treatment with the Alterra prestent and SAPIEN 3 THV
排除标准
- •Inability to tolerate an anticoagulation/antiplatelet regimen
- •Active bacterial endocarditis or other active infections
结局指标
主要结局
Acute Device Success
时间窗: 24 hours post-procedure
Acute Device Success, defined as a non-hierarchical composite of: * Single Alterra deployed in the desired location * Single THV implanted in the desired location within Alterra * Right ventricle-pulmonary artery peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation (PR) by discharge transthoracic echocardiogram * Free of Alterra/SAPIEN 3 explant at 24 hours post-implantation
次要结局
未报告次要终点