TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 831
- 主要终点
- Rate of Major Adverse Events (MAE)
研究概览
简要总结
The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.
详细描述
The TRICURE US IDE Pivotal Study is a prospective, global, multi-center, randomized (1:1) controlled study (RCT) designed to evaluate the safety and effectiveness of the TRiCares Topaz TTVR System compared to the Edwards EVOQUE TTVR System in subjects with severe or greater tricuspid regurgitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient is ≥ 18 years of age
- •Patient has severe or greater tricuspid regurgitation with symptoms despite optimal medical therapy
- •Patient is an appropriate candidate to undergo TTVR as determined by the Institution Heart Team
排除标准
- •Patient has a tricuspid device currently in place
- •Patient has anatomical contraindications
- •Patient is in need of urgent surgery
- •Patient has a left ventricular ejection fraction of < 25%
- •Patient has life expectancy of < 1 year
研究组 & 干预措施
TRiCares Topaz TTVR
Transcatheter tricuspid valve replacement with TRiCares Topaz TTVR
干预措施: TRiCares Topaz TTVR System (Device)
Edwards EVOQUE TTVR
Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR
干预措施: Edwards EVOQUE TTVR System (Device)
Single Arm Registry
Patients eligible to receive the TRiCares Topaz TTVR system, but not eligible for the Edwards EVOQUE system will be enrolled in the non-randomized, single-arm registry and treated with Topaz TTVR.
干预措施: TRiCares Topaz TTVR System (Device)
结局指标
主要结局
Rate of Major Adverse Events (MAE)
时间窗: 30 days post-procedure
Composite Endpoint
时间窗: 1 year post-procedure
All-cause mortality, heart failure hospitalization, non-elective tricuspid valve reintervention
次要结局
- Change in qualify of life (QoL)(1 year post-procedure)