NCT02210351Unknown不适用
Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in left ventricle ejection fraction
研究概览
简要总结
The asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography.
- •Symptomatic patients with aortic stenosis referred for medically indicated AVR
- •Signed informed consent to participate in the study.
排除标准
- •Inability to sign written informed consent.
- •Abnormal Apical dysfunction at baseline
- •LVEF < 20%
- •Pregnancy or breast feeding.
- •Need for emergency surgery for any reason.
- •Any case in which the practicing physician asserts that enrollment in the protocol will
研究组 & 干预措施
MRI test
Experimental
干预措施: MRI test (Device)
结局指标
主要结局
Change in left ventricle ejection fraction
时间窗: two months after the surgery
次要结局
未报告次要终点
研究者
Dr. Danny Spiegelstein
Dr. Danny Spiegelstein, Physician
Sheba Medical Center
研究点 (1)
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