NCT01238497已完成不适用
Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT
Edwards Lifesciences103 个研究点 分布在 8 个国家目标入组 2,954 人开始时间: 2010年9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
- 2,954
- 试验地点
- 103
- 主要终点
- Assess and track causality and sequelae of major adverse events
研究概览
简要总结
This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available Edwards SAPIEN XT™ Valve, and delivery devices.
详细描述
Consecutive patient data should be collected at discharge, 30 days and 12 months post-implant. Subsets of patients may undergo additional follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The SAPIEN XT™ THV is indicated for use in patients with symptomatic aortic stenosis requiring TAVI who have a high risk for operative mortality, or are "non-operable"
排除标准
- •Non-valvular or congenital aortic stenosis
- •Pre-existing prosthetic heart valve in the Aortic position or a non-calcified aortic valve
- •Severe (>3+) mitral insufficiency or aortic regurgitation > 3+
- •Active bacterial endocarditis or other active infections
- •Severe ventricular dysfunction with ejection fraction < 20%
- •Coronary artery disease-related unstable angina
- •Inability to tolerate anticoagulation / antiplatelet therapy
结局指标
主要结局
Assess and track causality and sequelae of major adverse events
时间窗: 30 days
次要结局
- Effectiveness: observe trends in patient characteristics and outcomes over time(One year)
研究者
研究点 (103)
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