NCT05486832招募中不适用
"TARGET Study": Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 13
- 主要终点
- Freedom from device or procedure-related adverse events
研究概览
简要总结
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system
详细描述
The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functional TR ≥3+
- •Symptomatic, NYHA Class II-IVa
- •Patient approved by the Subject Screening Committee
排除标准
- •Cardiac anatomy deemed not suitable for the Cardiovalve TR system
- •Hemodynamic instability
- •Severe right ventricular failure
- •Refractory heart failure requiring advanced intervention
研究组 & 干预措施
Cardiovalve TR replacement Group
Experimental
Cardiovalve TR valve replacement System
干预措施: Cardiovalve TR valve replacement System (Device)
结局指标
主要结局
Freedom from device or procedure-related adverse events
时间窗: 30 days
Freedom from device or procedure-related adverse events
Reduction in TR grade
时间窗: 30 days
Reduction in TR in comparison to baseline
次要结局
- Six minute walk test(30 days, 6 months, 12 months, annual for five years)
- KCCQ(30 days, 6 months, 12 months, annual for five years)
研究者
研究点 (13)
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