International Multisite Transcatheter Tricuspid Valve Therapies Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 269
- 试验地点
- 1
- 主要终点
- Cardiovascular Death
研究概览
简要总结
For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with significant morbidity and mortality. Hence, physicians tend to refer patients more aggressively to surgery (1).
Transcatheter procedures are an attractive alternative in high-risk patients. The field of transcatheter tricuspid devices has rapidly advanced over the last few years (2). Limited knowledge is available regarding the epidemiologic and anatomical settings in which these therapies are preferentially applied.
The main purpose of this registry is the collection of baseline clinical and anatomical data of the patients treated with transcatheter tricuspid valve therapies, and their outcomes, whenever feasible. Apart from more knowledge regarding the current status in this field, the results could also help the establishment of guidelines with respect to the choice of the transcatheter device selected and to understand which therapy can provide the better outcome in the different anatomies. Moreover, this study will provide important information about the epidemiology of severe tricuspid regurgitation, which is at the moment an undertreated disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients undergoing transcatheter tricuspid valve intervention.
- •General inclusion criteria:
- •Minimal age: 18 years
- •Patient is able to give written informed consent to the procedure
排除标准
- •Patients not fulfilling the indications for transcatheter tricuspid intervention
结局指标
主要结局
Cardiovascular Death
时间窗: 30 days
次要结局
- TR Reduction(30 days, 1 year)
- NYHA Class(30 days, 1 year)
