NCT03441971进行中（未招募）不适用
Evaluation of the GORE PV1 Device for Replacement of the Pulmonary Valve and Reconstruction of Right Ventricular Outflow Tract
W.L.Gore & Associates3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年6月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Valve-related mortality and device-related re-intervention
研究概览
简要总结
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit
- •Age ≥5 years at the time of informed consent signature.
- •Note: Additional Inclusion Criteria may apply
排除标准
- •An artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years).
- •Subjects with previously implanted pacemaker (including defibrillators).
- •Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.
- •Note: Additional Exclusion Criteria may apply
研究组 & 干预措施
Single Arm
Experimental
Participants will receive the device on Day 1.
干预措施: GORE PV1 (Device)
结局指标
主要结局
Valve-related mortality and device-related re-intervention
时间窗: 6 months
The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure
次要结局
- MRI change in right ventricular end diastolic volume index(6 months)
- MRI change in right ventricular end systolic volume index at 6 months(6 months)
- MRI change in left ventricular diastolic volume index at 6 months(6 months)
- MRI change in right ventricular ejection fraction at 6 months(6 months)
- Echo change in right ventricular diastolic area at 12 months(12 months)
- Six month pulmonary regurgitation < moderate(6 months)
- Echo change in right ventricular systolic area at 12 months(12 months)
- Echo change in left ventricular end diastolic volume index at 12 months(12 months)
- Echo change in right ventricular fractional area change at 12 months(12 months)
- Six month mean pressure gradient <= 40 mmHG(6 months)
- Twelve month mean pressure gradient <= 40 mmHG(12 months)
- Twelve month pulmonary regurgitation < moderate(12 months)
- Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months(1, 3, 6, 12, 24, 36, 48, and 60 months)
- All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months(1, 3, 6, 12, 24, 36, 48, and 60 months)
研究者
研究点 (3)
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