Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study
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
- 19
- 主要终点
- Device Success
研究概览
简要总结
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
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
- •Dysfunctional RVOT conduit or previously implanted surgical valve
- •RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg
排除标准
- •Inability to tolerate an anticoagulation/antiplatelet regimen
- •Active bacterial endocarditis or other active infections
研究组 & 干预措施
TPVR
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
干预措施: SAPIEN 3 THV (Device)
结局指标
主要结局
Device Success
时间窗: Discharge, expected to be within 1-5 days post-procedure
Defined as a composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery peak-to-peak gradient \< 35 mmHg post-implantation * Less than moderate PR by discharge TTE * Free of explant at 24 hours post-implantation
次要结局
未报告次要终点