Short Term Outcome of Aortic Root Enlargement in Management of Small Aortic Annulus Among Patients With Severe Valvular Aortic Stenosis
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHg
研究概览
简要总结
Aortic valve disease is a progressive illness that varies from minor valve thickening lacking obstruction of blood stream to severe calcification and alteration of the valve leading to weakened leaflet motion. Aortic valve replacement is a usual operation but can be complicated by a small aortic annulus requiring the insertion of an aortic valve prosthesis. Prosthesis-patient discrepancy results in worse outcomes.
详细描述
Prosthesis-patient discrepancy results in worse outcomes, including elevated left ventricular work, decreased left ventricular mass regression, and has also been linked with high mortality. Therefore, Aortic root posterior enlargement by autologous fixed pericardium to insert an Aortic valve prosthesis with size suitable to patient body surface area to avoid the previous worse outcome of patient prosthesis mismatch. In this study the investigators will try to identify the benefits of Aortic Root Enlargement in management of Small Aortic Annulus in Patients with severe valvular aortic stenosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •17-75 years old
- •patients with sever aortic valve stenosis undergoing valve replacement surgery
- •informed consent has been obtained
排除标准
- •Planned off-pump cardiac surgery
- •Patients required intra-aortic balloon pump
- •under 17 years of age
研究组 & 干预措施
Patients with sever aortic stenosis 1
Procedure: the patients will undergo aortic valve replacement with aortic root enlargement.
干预措施: procedure (Procedure)
Patients with sever aortic stenosis 2
Procedure: the patients will undergo conventional aortic valve replacement
干预措施: procedure (Procedure)
结局指标
主要结局
Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHg
时间窗: Baseline 6 weeks postoperative
Mild stenosis gradient 25 mmHg, Moderate stenosis gradient 25-40 mmHg, Sever stenosis gradient \>40 mmHg
次要结局
未报告次要终点
研究者
Mohamed mahmoud ahmed
Principal Investigator
Assiut University