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临床试验/NCT05411055
NCT05411055进行中(未招募)不适用

Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium

Maria Cecilia Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
postoperative complications

研究概览

简要总结

The Ozaki aortic valve reconstruction procedure uses autologous or bovine pericardium as an aortic cusp replacement without the use of struts and with use of the patient's own native aortic root. In this technique one can replace individual aortic cusps, 1, 2, or all 3 cusps. Ideally the patient's autologous pericardium will be harvested and fixed in gluteraldehyde at the time and prepared for the patient's specific annular dimensions with the neoaortic root sizers. Based on the measured size, one then uses a leaflet template to independently replace the cusps resulting in more effective preservation of the natural motion of the aortic valve annulus in coordination of the left ventricle, aortic annulus, sinus of Valsalva, and aorta compared to stented bioprosthetic and/or mechanical aortic valve replacements. Professor Ozaki has now performed 1000 Ozaki neoaortic valve reconstructive operations and has better than 95% freedom from re-operation at late follow-up. The objective of this study is to collect a large collection of prospective data from patients undergoing aortic neocuspidalization surgery for aortic valve insufficiency or stenosis isolated or combined with other procedures

研究设计

研究类型
Observational
观察模型
Case Only
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

  • severe aortic valve stenosis or insufficiency
  • Written informed consent
  • Willingness to carry out the follow-up visits

排除标准

  • Other types of aortic valve surgery

结局指标

主要结局

postoperative complications

时间窗: 5 years

次要结局

未报告次要终点

研究者

发起方
Maria Cecilia Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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