NCT06920745招募中不适用
TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Composite of heart failure hospitalization or all-cause mortality
研究概览
简要总结
This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system.
详细描述
The TRICARE will assess 2-year effectiveness in patients with symptomatic, severe or greater TR who undergo Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) with the TriClip system, as compared to a contemporaneous control of patients without T-TEER.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients ≥ 18 years of age at time of implant
- •Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group)
排除标准
- •Patients with less than severe Tricuspid Regurgitation
- •Patients with a prior history of surgical or transcatheter tricuspid valve replacement
- •Patients with a surgical or transcatheter aortic or mitral valve intervention within 90 days prior to index
结局指标
主要结局
Composite of heart failure hospitalization or all-cause mortality
时间窗: 2 years
Compare the rate of composite endpoint at 2 years between the treatment and control groups.
次要结局
- Tricuspid valve re-intervention(2 years)
研究者
研究点 (1)
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