NCT06862765已完成不适用
Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement with LuX-Valve Via the Trans-jugular Vein Approach
Xijing Hospital8 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2023年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 8
- 主要终点
- screening failure rate
研究概览
简要总结
The TRI-RECRUIT Study was conducted of 340 consecutive patients for TTVR screening using LuX-Valve via the trans-jugular vein approach at seven cardiac centers. Patient-level clinical records, imaging dates and screening outcomes were retrospectively collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •(i) age > 18 years old; (ii) TR severity ≥ severe; (iii) New York Heart Association (NYHA) functional class ≥ Ⅱ; (iv) failed GDMT; (v) Euro-SCORE > 4.
排除标准
- •(i) left ventricular ejection fraction < 40%; (ii) systolic pulmonary arterial pressure > 60 mmHg; (iii) prior TV surgery or left-sided valve surgery within the past 6 months; (iv) irreversible poor right ventricular function; (v) concomitant significant lesion needed for other major cardiac procedures or infective endocarditis.
结局指标
主要结局
screening failure rate
时间窗: baseline， postprocedural immediately，30 days postprocedurally，6 months postprocedurally，1 year postprocedurally
次要结局
未报告次要终点
研究者
Jian Yang
Prof.
Xijing Hospital
研究点 (8)
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