European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.
详细描述
Background and Rationale:
Tricuspid regurgitation (TR) is a major health and economic burden due to high rates of heart failure hospitalizations, morbidity and mortality. Surcial treatment of TR is associated with high procedural and in-hospital mortality. Due to prohibitive surgical risk, a significant proportion of patients historically remained untreted beyond medical therapy. Transcatheter tricuspid valve (TV) repair and replacement techniques (TTVT) now offer a new treatment perspective for these patients. The EuroTR registry aims at optimizing patient selection prior to TTVT and thus treatment quality by collecting respective data in a real-world setting.
Objectives:
To investigate clinical and survival outcome following transcatheter tricuspid valve repair or replacement.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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 treated with one of the following transcatheter devices for TV repair or replacement: PASCAL, TriClip, TricValve, Evoque, LuX-Valve
- •Age ≥ 18 years
排除标准
- 未提供
结局指标
主要结局
All-cause mortality
时间窗: 5 years
次要结局
- Technical success(5 years)
- Procedural Safety(5 years)
- Dyspnea on exertion(5 years)
- Right ventricular function(5 years)
- Tricuspid regurgitation reduction(5 years)
- Tricuspid valve stenosis(5 years)
- Heart Failure Biomarker(5 years)
- Pulmonary hypertension(5 years)
- Right ventricular size(5 years)
- Functional capacity(5 years)
- Right heart congestion(5 years)
- Hospitalization for heart failure(5 years)
研究者
Prof. Dr. med. Jörg Hausleiter
Deputy chief
LMU Klinikum