跳至主要内容
临床试验/NCT04350658
NCT04350658Unknown不适用

Feasibility and Safety of TAVI Without Predilatation: an Observational All Comers Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2020年6月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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