The Prospective LEUVEN Transcatheter Valve Therapy Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- All-cause death
研究概览
简要总结
Assessment of feasibility, safety and outcomes of transcatheter valve interventions
详细描述
Transcatheter valve therapies have a growing impact on daily medical practice since the first human percutaneous implantation of an aortic valve bioprosthesis by A. Cribier in 2002. While initially these techniques were reserved for patients at prohibitive risk for surgical aortic valve implantation, indications moving toward patients at high and intermediate risk.
Outcomes of these percutaneous interventions need to be monitored to assess quality of care and tailor indications in this rapidly moving field in interventional cardiology.
Trial objectives and Design Trial objectives
- to describe patient populations selected for transcatheter valve treatment
- to describe procedural aspects and results
- to perform clinical and hemodynamic follow-up of the patients Primary endpoints The primary endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium criteria (2-3).
Secondary endpoints The secondary endpoints of the study are hemodynamic outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium criteria (2-3). Quality of life parameters, as well as exercise tolerance will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry
排除标准
- •All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry. There are no formal exclusion criteria.
结局指标
主要结局
All-cause death
时间窗: 10 years of follow-up
The primary endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Cardiovascular death
时间窗: 10 years of follow-up
The primary endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
All-cause death and/or rehospitalisation for cardiovascular causes
时间窗: 10 years of follow-up
The primary endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
All-cause death and/or major stroke
时间窗: 10 years of follow-up
The primary endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
次要结局
- Exercise tolerance(2 years of follow-up)
- Bleeding complications(early after index intervention (30 days))
- Kidney injury(early after index intervention (30 days))
- Quality of life(10 years of follow-up)
- Clinical efficacy(10 years of follow-up)
- Rehospitalisation for cardiovascular causes(10 years of follow-up)
- Myocardial infarction(early after index intervention (30 days))
- Time-related valve safety(10 years of follow-up)
- Stroke(10 years of follow-up)
- Vascular complications(early after index intervention (30 days))
- Conduction disturbances and arrhythmias(early after index intervention (30 days))
- Device success(30 days of follow-up)
- Valvular function according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).(10 years of follow-up)
- Early safety(30 days of follow-up)