JPRN-UMIN000012426已完成未知
A multicenter trial to assess transcatheter aortic valve replacement for chronic hemodialysis patients with aortic valve stenosis - Transcatheter aortic valve replacement for chronic hemodialysis patients
Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital Heart Disease Center0 个研究点目标入组 20 人开始时间: 2013年12月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Acute myocardial infarction within 1 month 2. Unicuspid, bicuspid aortic valve, or aortic valve stenosis without calcification 3. Severe aortic valve regurgitation 4. Cardiac intervention within 2 weeks 5. Prior valve surgery with artifical valve ring or severe mitral valve regurgitation with level 3 or 4 6. Leukopenia, acute anemia, thrombocytopenic purpura, or past history of coagulation disorder 7. Coronary artery disease with significant stenosis requiring intervention. 8. Unstable circulation requiring mechanical support 9. Emergency procedure for any reason 10. Obstructive or nonobstructive cardiomyopathy 11. Severe LV dysfunction (LVEF<20%) 12. Cardiac tumor, thrombus, vegetation in UCG 13. Active gastrointestinal ulcer or history of upper gastrointestinal bleeding within 3 months 14. Allergy to aspirin, heparin, ticropigin, or contrast medium 15. Aortic valve annulus smaller than 18 mm or larger than 25 mm 16. CVA or TIA within 1 month 17. Life expectancy less than 12 months due to non-cardiac disease 18. Involvement in another clinical trial 19. Active bacterial endocarditis or other active infections 20. Massive calcified cusp of aortic valve close to the coronary ostium 21. Allergy to cobalt-chromium alloy 22. Abdominal or thoracic aortic aneurysm or atheroma (diameters more than 5 cm ), and serious denaturation or anatomical features of thoracoabdominal aorta 23. Severe calcification, extreme tortuosity and vessel diameter less than 6 mm making the safe insertion of sheath introducer impossible from the common iliac artery through the femoral artery
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