Feasibility and Safety of TAVI Without Predilatation: an Observational All Comers Study
试验速览
- 阶段
- 不适用
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- success of the direct implantation
研究概览
简要总结
The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
success of the direct implantation
时间窗: 1 day
success of the direct implantation defined as failure of crossing with the THV after 3 attemps and absence of complication related to the direct crossing
次要结局
- Indidence of post dilatation(1 day)
- Underexpansion of the Edwards SAPIEN 3 THV(1 day)
- risks factors of failure of crossing(1 day)
