JPRN-jRCTs042180025进行中（未招募）2 期
Clinical study of Patient-Specific Cardiac Support Net for dilated cardiomyopathy - PS-CS
Mutsuga Masato0 个研究点目标入组 3 人开始时间: 2019年1月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3
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
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1) Patients who sign the consent form of participating clinical study by their free will
- •2) Patients whose age are 20 years old or more, and 75 years or less at the time of obtaining informed consent
- •3) Patients with heart failure symptoms in spite of optimal drug oral treatment for heart failure of more than 3 months
- •4) Patients whom NYHA classification is III or IV, or level of INTERMACS Profile is 4 to 7
- •5) Patients with LVEDD more than 60 mm or LVEDDi more than 30 mm/m2 in echocardiography
- •6) Patients with LVEF less than 35% in echocardiography
- •7) Patients who have the intention of follow-up examination and observation, and can be admitted to visit the hospital which carries out them
排除标准
- •1. Patients with excessively enlarged heart. LVEDD is more than 85 mm
- •2. Patients with extremely low LVEF less than 10%
- •3. Patients with history of cardiac surgery except pacemaker implantation.
- •4. Patients who are scheduled for other cardiac surgery
- •5. Patients with the history or the schedule of CABG
- •6. Patients with the history or candidate of PCI or trans myocardial laser revascularization within 3 months
- •7. Patients who are implementing the IABP
- •8. Patients who are adapted to left ventricular assist devices or scheduled heart transplant
- •9. Patients with the history or schedule for ICD & CRT within 3 months
- •10. Patients whose life expectancy 1 year or less
- •11. Heart failure patients in end stage whose surgery risk is unacceptably high
- •12. Patients who have developed acute myocardial infarction, unstable angina within 3 months
- •13. Patients with hypertrophic cardiomyopathy
- •14. Patient with active infection
- •15. Patients with severe liver dysfunction whose AST or ALT values are more than 5 times of normal range in their institute.
- •16. Patients with poor lung function. FEV1 is less than 50%
- •17. Patients with severe renal failure. Serum creatinine is 3 mg/dL or more or patients with dialysis-dependent
- •18. Patients with diffuse peripheral vascular disease
- •19. Patients with history of cerebrovascular disease within 3 months
- •20. Patients with a high degree of bleeding tendency
- •21. Patients with blood clotting disorders
- •22. Patients who refuse blood transfusion
- •23. Patients with poor prognosis by malignant diseases
- •24. Patients with severe dementia, drug addiction, alcoholism
- •25. Patients with severe allergy
- •26. Pregnant or nursing patients. Patients who do not agree with contraception during the study
- •27. Patients participating in other studies
- •28. Patients whom the investigator determine unsuitable for participation
研究者
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