NCT01356108已完成不适用
Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position
Edwards Lifesciences16 个研究点 分布在 9 个国家目标入组 127 人开始时间: 2011年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 16
- 主要终点
- Safety
研究概览
简要总结
The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for patients with pulmonary regurgitation or stenosis.
详细描述
Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic with a regurgitant or stenotic pulmonary valved conduit.
排除标准
- •Angiographic evidence of coronary artery compression.
- •RV-PA pulmonary conduit size that is either too large or too small to accommodate the SAPIEN THV.
- •Thrombus or intracardiac mass in the right atrium, right ventricle, and/or pulmonic valve.
- •Severe coagulation problems and/or unable to tolerate anticoagulation/antiplatelet therapy.
- •Active bacterial endocarditis or other active infections.
- •Illeofemoral venous stenosis that may prevent the placement of the introducer sheath and/or central venous vascular tortuosities that may prevent advancement of the delivery system to the heart or into the pulmonary artery.
- •Presence of any prosthetic valve in the tricuspid position.
- •Unstable coronary artery disease-related angina.
- •Placement of the SAPIEN THV in pregnant females.
结局指标
主要结局
Safety
时间窗: 6 months
Procedure/Device Success and Freedom from device or procedure related death
次要结局
- Safety and Effectiveness(6 Months)
研究者
研究点 (16)
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