TAVI Registry at the National Research Center for Cardiac Surgery, Astana, Kazakhstan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of death
研究概览
简要总结
This study will analyze patients with aortic stenosis who have undergone transcatheter valve implantation and surgical aortic valve replacement. Afterwards, the results of these two procedures will be collected to the database and compared among the Kazakhstani population.
详细描述
Primary Objectives
- Prevalence of aortic stenosis in Kazakhstan regions
- 12 months survival of patients after TAVI
- Intra- and postoperative complications
- Conduction disorders after TAVI
- Left ventricle function after TAVI in patients with low ejection fraction
- Comparison of aortic route dimensions by 3D-TEE and MSCT
- Comparison of TAVR with SAVR
Study Design Registry, IV phase
Subject Follow-up Schedule Maximum follow-up is approximately 4 years.
Inclusion Criteria Patients have TAVI
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients has given written informed Concent for study participation prior to procedure
- •Patients with Aortic Valve stenosis
- •Patients has severe degenerative or congenital aortic stenosis.
- •Patients has symptomatic aortic stenosis as demonstrated by NYHA II or greater
排除标准
- •Patients has active endocarditis
- •Patients has history of cerebral vascular accident or transient ischemic attack within the past 3 months
结局指标
主要结局
Number of death
时间窗: 1 year
12 month all-cause of mortality
Incidence of stroke
时间窗: within 30 days and 12 months
procedure associated stroke and 12 months
Permanent pacemaker implantation
时间窗: within 30 days
procedure associated AB block which is need for permanent pacemaker implantation
Evaluate of echocardiographic results
时间窗: 1 year
echocardiographic parameters: Aortic valve orifice area, aortic valve bioprosthetic gradient (peak, mean), aortic valve bioprosthetic velocity, ejection fracrion of left ventricle (LVEF%).
次要结局
- Life quality(Baseline, 12 months)
研究者
Abdurashid
Head of the department of the catheterization laboratory
National Research Center for Cardiac Surgery, Kazakhstan