NCT03039855已完成不适用
Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 39
- 主要终点
- Reduction of Mitral Regurgitation to optimal or acceptable
研究概览
简要总结
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
详细描述
The TIARA-II study is an international, multicenter, single-arm, prospective, safety and performance clinical study.
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
- •High surgical risk for open mitral valve surgery
- •Subject meets anatomical eligibility criteria
排除标准
- •Deemed too frail by objective frailty assessments
- •Previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant
- •Unsuitable cardiac structure
- •Clinically significant untreated Coronary Artery Disease (CAD)
- •Subjects on chronic dialysis
- •Pregnant or planning pregnancy within next 12 months
- •Documented bleeding or coagulation disorders
- •Active infections requiring antibiotic therapy
- •Subjects with a life expectancy less than 12 months
结局指标
主要结局
Reduction of Mitral Regurgitation to optimal or acceptable
时间窗: 30 days
Freedom from all-cause mortality
时间窗: 30 days
Freedom from major adverse events
时间窗: 30 Days
次要结局
- Procedural success(30 days)
- Kansas City Cardiomyopathy Questionnaire(30 days, 90 days, 180 days and once annually for five years)
- Freedom from all-cause mortality(90 days, 180 days, one year and annually to five years)
- Hemodynamic performance(30 days, 90 days, 180 days and once annually for five years)
- NYHA Functional Class(30 days, 90 days, 180 days and once annually for five years)
- Patient success(1 year)
- Freedom from major adverse events(90 days, 180 days, one year and annually to five years)
- Technical success(Day 0)
- Device success(Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years)
- 6 Minute Walk Test(30 days, 90 days, 180 days and once annually for five years)
研究者
研究点 (39)
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