NCT03699345已完成不适用
Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System
Edwards Lifesciences11 个研究点 分布在 6 个国家目标入组 87 人开始时间: 2019年1月7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
- 87
- 试验地点
- 11
- 主要终点
- All-Cause Mortality
研究概览
简要总结
This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
详细描述
A prospective, international, single arm, multi-center post market clinical follow-up study.
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
- •Severe native valve calcific aortic stenosis
- •Judged by the Heart Team to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator).
排除标准
- •Known hypersensitivity to Nitinol (nickel or titanium)
- •Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
- •Inability to tolerate anticoagulation/antiplatelet therapy
结局指标
主要结局
All-Cause Mortality
时间窗: 30 days
All-cause mortality at 30 days
次要结局
未报告次要终点
研究者
研究点 (11)
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