NCT05126030进行中（未招募）不适用
TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First in Human Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- TRiCares
- 入组人数
- 20
- 试验地点
- 20
- 主要终点
- Hierarchical composite endpoint
研究概览
简要总结
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
详细描述
The TRiCares Topaz Prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.
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
- •Subject of age >18 years.
- •Subject with severe symptomatic tricuspid regurgitation presenting following conditions:
- •TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or
- •symptoms requiring use of diuretics.
- •Subject presenting with New York Heart Association Class NYHA ≥II.
- •Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision.
排除标准
- •Subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months.
- •Subject undergoing cardiac interventions within 30 days prior to index procedure.
- •Subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis.
- •Subject who had previous tricuspid valve replacement or repair and a device is still in situ.
结局指标
主要结局
Hierarchical composite endpoint
时间窗: 30 days
including all-cause mortality, re-hospitalization for heart failure, re-intervention for failed tricuspid intervention, and KCCQ worsening at 30 days
次要结局
未报告次要终点
研究者
研究点 (20)
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