Re-hospitalisation After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI
研究概览
简要总结
The goal of this study is to investigate whether patient-tailored follow-up for patients treated with transcatheter aortic valve implantation (TAVI) can prevent re-hospitalisation and improve quality of life compared with the standard follow-up program.
The rationale of this study is the persistently high rate of re-hospitalisation after TAVI, which increases the risk of mortality and diminishes the patient-evaluated quality of life. Our hypothesis is that patient-tailored follow-up for patients treated with TAVI will reduce the rate of re-hospitalisation after the TAVI-procedure and improve quality of life.
The primary endpoints are the rate of re-hospitalisation within 90 days of the procedure and quality of life adjusted life years at 90-day follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent technical successful TAVI
- •Residing in Denmark
- •Provided written informed consent
排除标准
- •Index admission mortality
- •Index admission conversion to open surgery
- •Age < 18 years
- •Women of childbearing potential, pregnant or nursing
结局指标
主要结局
The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI
时间窗: 365 days
Primary safety endpoint
Quality-of-life adjusted life years at 90 days after the TAVI-procedure
时间窗: 365 days
Primary efficacy endpoint
次要结局
- The risk of all-cause mortality(365 days)
研究者
Ole De Backer
Professor, dr. med.
Rigshospitalet, Denmark