跳至主要内容
临床试验/NCT07296016
NCT07296016尚未招募不适用

The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry

Prince of Wales Hospital, Shatin, Hong Kong1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

A significant number of patients with severe mitral and tricuspid valve disease have been previously treated with either valve repair with annuloplasty rings or valve replacement with bioprosthetic/mechanical valves. Over time, these bioprosthetic valves and rings may fail resulting in recurrence of the valvular disease. The technical aspects of a re-do operation are complex and these patients are often times at high risk for repeat open surgery. The emergence of transcatheter options may provide a safer and less invasive alternative to open surgery. Majority of the data currently exist for Western cohorts with limited longer-term outcomes. Data on this therapy is particularly lacking in the Asia-Pacific region, especially important in the light of known differences in body habitus and size.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Had at least one documented Mitral valve-in-valve/valve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Mitral valve-in-valve/valve-in-ring procedure. (Prospective) OR Had at least one documented Tricuspid valve-in-valve/valve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Tricuspid valve-in-valve/valve-in-ring procedure. (Prospective)

排除标准

  • Active endocarditis
  • Any other conditions which investigator deems unsuitable for participation.

结局指标

主要结局

All-cause mortality

时间窗: 10 years

Rate of All-cause mortality in enrolled patients

次要结局

  • Procedural technical success rate(Immediately after operation)
  • Procedural complication rate(Periprocedural)
  • Major adverse cardiovascular events rate(10 years)
  • New York Heart Association (NYHA) classification(10 years)
  • Echocardiographic result(10 years)

研究者

发起方
Prince of Wales Hospital, Shatin, Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr So Chak Yu kent

Clinical Assistant Professor

Prince of Wales Hospital, Shatin, Hong Kong

研究点 (1)

Loading locations...

相似试验

The Asia-Pacific Mitral & Tricuspid... | 临床试验