跳至主要内容
临床试验/NCT03416166
NCT03416166招募中不适用

International Multisite Transcatheter Tricuspid Valve Therapies Registry

University of Zurich1 个研究点 分布在 1 个国家目标入组 269 人开始时间: 2016年11月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验