Etude Multicentrique Évaluant L'efficacité D'une Intervention Visant À Réduire La Durée De Séjour Après L'implantation D'une Bioprothèse Aortique Par Voie Transfémorale
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,842
- 试验地点
- 20
- 主要终点
- To evaluate the effectiveness of a multi-component organizational intervention
研究概览
简要总结
Since the first implantation of a percutaneous aortic bioprosthesis (TAVI) in 2002 (Cribier et al. Circulation 2002), TAVI occupies an increasing place in the management of aortic stenosis (AR) . Initially reserved for inoperable patients at high surgical risk, TAVI is also recommended in patients at intermediate risk, especially when a femoral approach (TF) is possible (Baumgartner et al. Eur Heart J. 2017).
Currently, there is no recommendation regarding length of stay after TAVI and practices are extremely heterogeneous. Despite the growing experience of centers, better patient selection and a reduction in complications, the length of stay after TAVI remains very high in France.
Faced with the great disparity observed between the centers, efforts are necessary to educate the centers in order to further reduce the length of stay after TF-TAVI. The aim of the study is to evaluate the effectiveness of an intervention based on training teams to reduce the length of stay after TF-TAVI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patient over 18 years of age;
- •Patient hospitalized for TF-TAVI
- •Patient affiliated or benefiting from a health insurance scheme
- •Patient having read and understood the information letter and having signed the consent form.
排除标准
- •Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ; 1
- •Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship
- •History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent
结局指标
主要结局
To evaluate the effectiveness of a multi-component organizational intervention
时间窗: Year 1
Proportion of patients benefiting from TF-TAVI with a length of stay less than or equal to 3 days.
次要结局
- To evaluate the implementation of the intervention(Year 1)
- To identify the factors associated with the effectiveness and safety of the intervention(Year 1)
- To evaluate the safety of the intervention(Day 30)
- To evaluate the budgetary impact of the intervention(Year 1)