NCT02987387已完成不适用
New Enrollment SAPIEN XT Post-Approval Study
Edwards Lifesciences12 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2017年7月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 12
- 主要终点
- Freedom from device- or procedure-related death or reintervention
研究概览
简要总结
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.
详细描述
The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.
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
- •Patient has a dysfunctional, non-compliant RVOT conduit.
- •The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
排除标准
- •Inability to tolerate an anticoagulation/antiplatelet regimen
- •Active bacterial endocarditis
结局指标
主要结局
Freedom from device- or procedure-related death or reintervention
时间窗: 1 year
次要结局
- Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions(1 year)
- Decrease in pulmonary regurgitation to mild or less for regurgitant lesions(1 year)
- Device Success(48 Hours Prior to Discharge)
研究者
研究点 (12)
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