NCT02428010终止不适用
Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Medtronic Cardiovascular1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Study to evaluate the safety and performance of the Twelve TMVR System
详细描述
The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high risk patients with severe, symptomatic mitral regurgitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe mitral regurgitation (MR Grade 3-4+)
- •Symptomatic mitral regurgitation (NYHA Class II-IV)
- •Trans-apical access deemed feasible by the treating physician
- •Native mitral valve geometry and size compatible with the Twelve TMVR
排除标准
- •Left ventricular ejection fraction (LVEF) < 20
- •Evidence of intracardiac mass, thrombus, or vegetation
- •Prior valve surgery or need for other valve surgery
- •Prior stroke within 4 weeks
- •Need for coronary revascularization
- •History of, or active, endocarditis
- •Renal insufficiency (Creatinine > 2.5 mg/dL)
结局指标
主要结局
Adverse Events
时间窗: 30 days
Number of patients with adverse events associated with the delivery and/or implantation of the device
次要结局
- Reduction of MR(Through 5 years)
- Procedural Success(Through 5 years)
研究者
研究点 (1)
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