The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry
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
- 否
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
Dr So Chak Yu kent
Clinical Assistant Professor
Prince of Wales Hospital, Shatin, Hong Kong
