NL-OMON37451
撤回
不适用
ACURATE TA* Transapical Aortic Bioprosthesis for Implantation in Patients with Severe Aortic Stenosis - 2011-01 ACURATE TA*
SYMETIS S.A.0 个研究点目标入组 10 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Severe Aortic Stenosis
- 发起方
- SYMETIS S.A.
- 入组人数
- 10
- 状态
- 撤回
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Patients 70 years of age and older
- •2\. Additive EuroSCORE \* 9
- •3\. Severe aortic stenosis characterized by mean aortic gradient \> 40 mmHg or peak jet
- •velocity \> 4\.0 m/s or aortic valve area of \*1\.0 cm2
- •4\. NYHA Functional Class \> II
- •5\. Aortic annulus diameter from \* 21mm up to \* 27mm by TEE
- •6\. Patient willing to participate in the study and provides signed informed consent
排除标准
- •1\. Congenital unicuspid or bicuspid aortic valve
- •2\. Severe eccentricity of calcification
- •3\. Severe mitral regurgitation (\> 2°)
- •4\. Pre\-existing prosthetic heart valve in any position and / or prosthetic ring
- •5\. Severe transapical access problem, non\-reachable LV apex
- •6\. Previous surgery of the LV using a patch, such as the Dor procedure
- •7\. Presence of apical LV thrombus
- •8\. ECHO evidence of intracardiac mass, thrombus, or vegetation
- •9\. AMI within 1 month prior to the procedure
- •10\. PCI within 1 month prior to the procedure
结局指标
主要结局
未指定
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