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临床试验/NCT00486928
NCT00486928已完成不适用

Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 816 人开始时间: 2004年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
816
试验地点
1

研究概览

简要总结

Background-:. The Medtronic-Hall (MH) valve was developed and for the first time implanted in Oslo in 1977. A total of 1,104 patients received this valve at Rikshospitalet-Radiumhospitalet HF in the period 1977-87. In the present study we followed all 816 patients undergoing aortic valve replacement (AVR) over a 25-year period.

详细描述

The Medtronic-Hall (MH) tilting valve disk was first implanted in Oslo in June 1977. From 1977 through 1987, the valve was used as the only valve of choice and inserted in a total of 1,104 consecutive patients at our department.

The MH valve is made of a single piece of titanium with no welds. The disk is made of tungsten impregnated graphite with a carbon pyrolytic coating. The tungsten renders the disk radiopaque. In the aortic position the maximal opening is 75˚. A central aperture in the disk allows free rotation. The valve is rotatable in the sewing ring. The sewing ring is made of Teflon. Aortic sizes are 20-31 mm (outer diameter).

The initial clinical results were published in 1979 (1). The cohort of patients has been followed-up and analysed at 5, 10 and 15 years (2-5). In the present study we report our 25-year follow-up data for the 816 patients undergoing aortic valve replacement (AVR) with special reference to survival, functional status, valve-related complications and the impact of concomitant surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients with aortic valve replacement 1977-87

排除标准

  • 未提供

研究者

发起方
Oslo University Hospital
申办方类型
Other

研究点 (1)

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