Safety, Clinical Efficacy and Time-to-event Survival in Patients With Degenerative Aortic Valve Disease Scheduled for Stented Biological Aortic Valve Replacement Versus Allograft Aortic Root Replacement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 主要终点
- Mortality
研究概览
简要总结
The aim of the observational study is to compare safety, clinical efficacy and time-to-event survival in patients age of 60-74 years with degenerative aortic valve disease that underwent aortic valve replacement with either stented biological prosthesis or aortic allograft.
详细描述
Early safety included morbidity, mortality rate, freedom from any valve related complications Clinical efficacy included mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication Time-to-event analysis included freedom from all-cause and cardio-vascular mortality, freedom from stroke, major bleeding, endocarditis, structural valve deterioration and reoperation
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 60 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with degenerative aortic valve disease not emendable for aortic valve repair
- •Elective surgery
排除标准
- •Left ventricle ejection fraction less than 40%
- •Redo surgery
- •Indication for concomitant mitral valve replacement
- •Aortic valve/root endocarditis
- •Severe COPD
- •Dialysis patients
结局指标
主要结局
Mortality
时间窗: 30 days
Early cardio-vascular mortality
次要结局
- Mortality(2 years)
- Structural valve deterioration(2 years)
- Stroke(2 years)
- Reoperation(2 years)
- Endocarditis(2 years)
研究者
Mikhail Nuzhdin
Director
Chelyabinsk Regional Clinical Hospital