DRKS00013491已完成3 期
ACURATE TF Transfemoral Aortic Bioprosthesis for Implantation in patients with severe aortic stenosis - ACURATE TF 2013-01
Symetis SA0 个研究点目标入组 39 人开始时间: 2018年2月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 75 Years 至 one（—）
- 性别
- All
入选标准
- •1. Patient 75 years of age and older
- •2. Severe aortic stenosis defined as:
- •o Mean aortic gradient > 40 mmHg or
- •o Peak jet velocity > 4.0 m/s or
- •o Aortic valve area of < 1.0 cm2
- •3. High risk candidate for conventional AVR defined as:
- •o Logistic EuroSCORE 1 = 20 or
- •o Heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co-morbid conditions unrelated to aortic stenosis
- •4. NYHA Functional Class > II
- •5. Aortic annulus diameter from = 21mm up to = 27mm by CT or TEE
- •6. Patient willing to participate in the study and provides signed informed consent
排除标准
- •1. Unicuspid or bicuspid aortic valve
- •2. Extreme eccentricity of calcification
- •3. Severe mitral regurgitation (>2+)
- •4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring
- •5. Aortic or peripheral anatomy NOT appropriate for transfemoral implant
- •6. Thoracic (TAA) or abdominal (AAA) aortic aneurysm
- •7. Presence of endovascular stent graft for treatment of TAA or AAA
- •8. Trans-esophageal echocardiogram (TEE) is contraindicated
- •9. ECHO evidence of intracardiac mass, thrombus, or vegetation
- •10. LVEF < 30% by ECHO
- •11. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
- •12. AMI within 1 month prior to implant procedure
- •13. Previous TIA or stroke within 3 months prior to implant procedure
- •14. Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure
- •15. Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
- •16. History of bleeding diasthesis, coagulopathy, anemia, leucopenia or refusal of blood transfusions
- •17. Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP
- •18. Primary hypertrophic obstructive cardiomyopathy (HOCM)
- •19. Active infection, endocarditis or pyrexia
- •20. Hepatic failure (> Child B)
- •21. Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis
- •22. Refusal of surgery
- •23. Severe COPD requiring home oxygen
- •24. Neurological disease severely affecting ambulation or daily functioning, or dementia
- •25. Life expectancy < 12 months due to non-cardiac co-morbid conditions
- •26. Contraindication to study medication, contrast media, or allergy to nitinol
- •27. Currently participating in an investigational drug or another device study
研究者
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