German Registry for Transcatheter Tricuspid Valve Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- All-cause death and heart failure hospitalisation
研究概览
简要总结
Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.
详细描述
Severe tricuspid regurgitation occurs in around 1.5 % of men and 5.6 % of women and it is associated with significant morbidity and mortality. Current guidelines recommend cardiac surgery, especially in those patients who are undergoing left side valve surgery. Nevertheless many patients are not eligible for surgical tricuspid valve repair due to an high risk of mortality. Therefore interventional devices for treatment of tricuspid regurgitation have been established to offer these patients an alternative treatment option. The aim of this study is to analyse the success and saftey aspects of different interventional repair techniques for severe tricuspid regurgitation. Therefore in this prospectively designed observational study clinical, echocardiographic and laboratory parameters will be collected.
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
- •Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair
- •Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission.
排除标准
- •No agreement to participation
- •Age < 18 years
结局指标
主要结局
All-cause death and heart failure hospitalisation
时间窗: 1 year
All-cause death and heart failure hospitalisation 1 year after transcatheter tricuspid valve treatment (TTVT)
次要结局
- Change of 6-minute walking distance test after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)
- Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)
- Change of NT-proBNP after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)
- Procedural success after transcatheter tricuspid valve treatment (TTVT)(At the day of discharge after transcatheter tricuspid valve treatment (TTVT))
- All-cause death and heart failure hospitalisation (long-term)(up to 5 years)
- Change of quality of life after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)
- All-cause death and heart failure hospitalisation (short-term)(30-90 days)
- Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)
- Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)
研究者
Prof. Dr. med. Jörg Hausleiter
Professor
LMU Klinikum