跳至主要内容
临床试验/NCT04696926
NCT04696926已完成不适用

Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve: a Single-center Prospective Study

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
5-year overall mortality

研究概览

简要总结

Objectives:

This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.

Methods:

All consecutive patients who underwent an aortic valve replacement with an Edwards Intuity TM bioprosthesis at La Timone Hospital, Marseille, France, were prospectively included between July 2012 and June 2015 and were followed for 5 years. The primary outcome was overall mortality at 5 years.

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

  • Consecutive patients implanted by the Intuity TM bioprosthesis
  • For severe aortic valve stenosis or severe aortic regurgitation
  • Including reoperation and combined surgery
  • Between July 2012 and June 2015

排除标准

  • absence of patient's authorization for anonymous publication of their clinical data for research purposes

结局指标

主要结局

5-year overall mortality

时间窗: 5 years

overall mortality

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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