NCT06506942招募中不适用
The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- TRiCares
- 入组人数
- 15
- 试验地点
- 16
- 主要终点
- Composite of MAE
研究概览
简要总结
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
详细描述
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
- •Institutional Heart Team evaluates patient as being at increased operative risk
排除标准
- •Patient in need of emergent intervention
- •Patient who is hemodynamically unstable
- •Anatomical contraindications for implantation with study device
- •Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
研究组 & 干预措施
Transcatheter Tricuspid Valve Replacement
Experimental
Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System
干预措施: Transcatheter Tricuspid Valve Replacement (Device)
结局指标
主要结局
Composite of MAE
时间窗: 30 day post-intervention
Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.
Device Success
时间窗: immediately post-intervention
Device success defined as a reduction in tricuspid regurgitation immediately post-intervention
次要结局
- Six minute walk test(30 days, 6 months, annual for five years post-intervention)
- Reduction in Tricuspid Regurgitation (TR) Grade(30 days, 6 months, annual for five years post-intervention)
- New York Heart Association (NYHA) Function Class(30 days, 6 months, annual for five years post-intervention)
研究者
研究点 (16)
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