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临床试验/NCT02278666
NCT02278666已完成不适用

Minimally Invasive Aortic Valve Replacement Versus Conventional Aortic Valve Replacement: a Long Term Registry on Potential Benefits of the Different Surgical Techniques

Maria Cecilia Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2014年10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
1,000
试验地点
1
主要终点
Total duration of Intensive Care Unit stay

研究概览

简要总结

The aim of the present study is to assess in a "real life" case list the outcome of three different surgical approaches for isolated aortic valve surgery in terms of surgery times, morbidity and mortality.

详细描述

The study will focus on data recorded and collected from daily clinical treatment of patients undergoing isolated aortic valve replacement due to symptomatic aortic stenosis who consented to the use of their personal data. After surgery patients will be followed up to a minimum of 12 months. In-hospital and follow-up outcomes of the different surgical approaches will be analysed.

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

  • All patients undergoing isolated aortic valve surgery
  • Written Informed consent to the use of personal data

排除标准

  • other associated cardiac surgery
  • emergency surgery

结局指标

主要结局

Total duration of Intensive Care Unit stay

时间窗: during hospital stay, usually lasting one to two weeks

Blood transfusions

时间窗: during hospital stay, usually lasting one to two weeks

Cardiopulmonary bypass time

时间窗: during surgery

次要结局

  • in-hospital mortality(during hospital stay, usually lasting one to two weeks)
  • 30-day mortality(30 days after surgery)
  • sepsis(during hospital stay, usually lasting one to two weeks)
  • Neurological complications(during hospital stay, usually lasting one to two weeks)
  • Prolonged ventilation(during hospital stay)
  • renal insufficiency(during hospital stay, usually lasting one to two weeks)
  • Re-exploration for bleeding(during hospital stay, usually lasting one to two weeks)

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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