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临床试验/NCT05055089
NCT05055089已完成不适用

Short- and Medium-term Outcomes of New Generation Biological Aortic Valves in Aortic Valve Replacement Surgery

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2021年9月6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
172
试验地点
1
主要终点
Variation of mortality rate between both groups

研究概览

简要总结

Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used. In parallel with the historical biological prostheses for aortic valve surgery, a new generation of bioprostheses has been marketed since 2008, with the entry of these new prostheses in the armatorium of the Amiens-Picardy University Hospital since 2010. These are rapid deployment prostheses or prostheses without sutures. As a result, patients undergoing aortic valve replacement have been able to benefit from this type of bioprosthesis during their procedures. There are few publications reporting the 5-year follow-up of these bioprostheses. The investigators therefore decided to follow up patients operated on by a new generation bioprosthesis to study the 5-year survival and the functioning of their bioprostheses, in order to make a scientific contribution to the follow-up of these valves. These patients will be compared to patients who have benefited from the implantation of traditional bioprostheses.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • •Retrospectively included all patients examined since
  • •Patients who have aortic valve surgery from the Cardiac Surgery Department of the University Hospital of Amiens.

排除标准

  • •Refusal to participate in the patient.
  • •Patients who have previously had aortic valve surgery.

研究组 & 干预措施

new-generation bioprostheses

Patients undergoing surgical aortic valve replacement with new-generation bioprostheses

traditional bioprosthesis

patients who received a traditional bioprosthesis

结局指标

主要结局

Variation of mortality rate between both groups

时间窗: 3 months

both groups are : * Patients undergoing surgical aortic valve replacement with new-generation bioprostheses * Patients who received a traditional bioprosthesis

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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