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
- 1,500
- 试验地点
- 2
- 主要终点
- All-cause mortality
研究概览
简要总结
This study is a retrospective and prospective, observational, multicenter cohort study of consecutive patients undergoing transcatheter mitral or tricuspid ViV or ViR procedure with balloon expandable valve.The emergence of transcatheter options may provide a safer and less invasive alternative to open surgery.So hence, since the data on this therapy is particularly lacking in the Asia-Pacific region, especially importantly in the light of known differences in body habitus and size- the main aim of the study is to: Describe the real-world use of transcatheter mitral or tricuspid ViV/ViR in Asia-Pacific, determine predictors of procedural success, determine predictors of major procedural complications and to evaluate short or intermediate or long term safety and efficacy outcomes and its determinants.Data related to patient’s procedure will be collected and stored at the National Heart Centre Singapore (NHCS). Statistical analyses will be conducted using Stata version 16.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age equal to or more than 21
- •Had at least one documented Mitral valve-in-valve or 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 or valve-in-ring procedure.
- •(Prospective) OR Had at least one documented Tricuspid valve-in-valve or 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 or 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: Ongoing up to 13 years
次要结局
- Procedural technical success (defined per Mitral Valve Academic Research Consortium (MVARC) criteria at exit from the hybrid suite as patient alive with successful access, delivery, and retrieval of the device delivery system, successful deployment and correct position of the first intended device, and freedom from emergency surgery or reintervention associated with the device or access procedure)(Ongoing up to 13 years)
- Procedural or In-hospital complications(Ongoing up to 13 years)
- Major adverse cardiovascular events (Cardiovascualr mortality, Myocardial Infraction, stroke,etc)(Ongoing up to 13 years)
- The New York Heart Association (NYHA) class(Ongoing up to 13 years)
- Echocardiographic variables(Ongoing up to 13 years)
研究者
Dr Ajit MullasariS
The Madras Medical Mission