NCT02815514已完成不适用
Deutsches TAVI-Register
Stiftung Institut fuer Herzinfarktforschung1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2009年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
The TAVI - Register is a Germany-wide scientific elevation in which data about the aortic valve treatment and the therapeutic consequences are documented.
详细描述
Documentation of all consecutive patients of the participating centers with significant aortic stenosis, undergoing one of the following therapies:
- Percutaneous transfemoral aortic valve replacement
- Percutaneous aortic valve replacement transapical
- Percutaneous aortic valve replacement transaortic
- Aortic valve balloon valvuloplasty
- Surgical aortic valve replacement
- Conservative treatment
- Documentation of the indications, procedural results and clinical short-and long-term results of the above therapies
- Documentation of operational risk and quality of life
- Documentation of the technical implementation of the procedure and success of the intervention and of hospital reinterventions
- Documentation of hospital mortality, nonfatal major complications (stroke, TIA, myocardial infarction, dialysis, vascular complications, bleeding, neuropsychological status)
- Documentation of discharge medication and the length of hospital stay
- Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis, the reintervention and quality of life and of drug therapy within 30 days, 1 year, 3 years and 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with aortic stenosis (degree III) who received one of the following therapies:
- •transapical operative aortic valve implantation
- •operative aortic valve implantation
- •percutaneous aortic valve implantation
- •balloon valvuloplasty
排除标准
- •missing signed informed consent
结局指标
主要结局
All cause mortality
时间窗: 5 years
次要结局
- Short- and long-term results of the documented therapies(5 years)
- Details on operational risk(up to four weeks)
- Details of performed procedures(up to four weeks)
- Complications during hospital stay(up to four weeks)
- Details of hospital stay(up to four weeks)
- Serious long-term complications(5 years)
- Quality of life(5 years)
- Drug treatment(5 years)
研究者
研究点 (1)
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