TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 28
- 主要终点
- Number of patients with readmission for HF
研究概览
简要总结
Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.
详细描述
The study shall enrol subjects who were treated with the TricValve® Transcatheter Bicaval Valves System® in the Inferior Vena Cava and Superior vena cava. On compliance with the inclusion / exclusion criteria the subject will be enrolled for the observational study.
The study duration for the individual subject will be up to 5 year follow up. The follow-up should be made through pre-established periodic clinical consultations at discharge, 1 month, 6 months, 1 year follow up to 5 years after the procedure. In the consultations, routine exams such as hemogram, renal function, electrocardiogram and echocardiography in order to ascertain the bioprosthesis functioning and its hemodynamic profile are documented as per clinical routine practise.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Successful treatment with TricValve Transcatheter Bicaval Valves System
- •Patient/patient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent
排除标准
- •no exclusion criterion
结局指标
主要结局
Number of patients with readmission for HF
时间窗: up to 12 months
First unplanned readmission for Heart Failure
次要结局
- Change in BNP/NTproBNP and diuretic dosage(up to 12 months)
- All cause mortality(up to 30 days, up to 6 months, up to 5 years)
- NYHA functional class(up to 30 days, up to 6 months, up to 5 years)
- Percentage of participants with major adverse events(up to 12 months)
- Number of patients with readmission for HF(up to 5 years)
- Number of participants with severe adverse events(up to 30 days, up to 6 months, up to 5 years)
- Change of the right atrium size(up to 30 days, up to 6 months, up to 5 years)
- Change of the free valve movement(up to 30 days, up to 6 months, up to 5 years)
- Valve Device Regurgitation(up to 30 days, up to 6 months, up to 5 years)
- Number of alive patients(up to 30 days, up to 6 months, up to 5 years)