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 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 10
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
- 18 至 99（—）
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
- •11. Previous TIA or stroke in the last 3 months
- •12. Untreated coronary artery disease (CAD) requiring revascularization
- •13. Hemodynamic instability: systolic pressure <90mmHg without afterload reduction,
- •shock, need for inotropic medication or IABP
- •14. LVEF < 30% by ECHO
- •15. Calcified pericardium
- •16. Septal hypertrophy unacceptable for transapical procedure
- •17. Primary hypertrophic obstructive cardiomyopathy (HOCM)
- •18. Active infection, endocarditis or pyrexia
- •19. Active peptic ulcer or gastrointestinal (GI) bleeding within the past 3 months
- •20. Liver failure
- •21. Severe COPD requiring home oxygen
- •22. Blood dyscrasias: leukopenia (WBC < 3000mm3), acute anemia (Hb < 9 mg%),
- •thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis
- •or coagulopathy
- •23. Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis
- •24. Neurological disease severely affecting ambulation or daily functioning
- •25. Senile dementia
- •26. Another surgical or percutaneous procedure scheduled at the same time
- •27. Emergency procedure pre-implant
- •28. Life expectancy < 12 months due to non-cardiac co-morbid conditions
- •29. Known hypersensitivity/contraindication to study medication, contrast media, or
- •30. Currently participating in an investigational drug or another device study
研究者
相似试验
已完成
3 期
ACURATE TF Transfemoral Aortic Bioprosthesis for Implantation in patients with severe aortic stenosisI35.0Aortic (valve) stenosisDRKS00013491Symetis SA39
已完成
不适用
ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic StenosisAortic StenosisNCT02986737Symetis SA15
撤回
不适用
ATS 3f Enable* Aortic Bioprosthesis pivotal studyNL-OMON32374ATS Medical Inc.30
招募中
不适用
ACURATE neo Trademark Aortic Bioprosthesis for Implantation using the ACURATE TF Trademark Transfemoral Delivery System in Patients with Severe Aortic Stenosis in an Australian PopulatioACTRN12616000064404Reid Healthcare100
已完成
不适用
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval CohortSymptomatic Aortic StenosisNCT03003650Symetis SA89