JPRN-jRCTs052180006已完成未知
Clinical research of the left ventricular assist device with post-auricular connector - Clinical research of the left ventricular assist device with post-auricular connector
Sawa Yoshiki0 个研究点目标入组 3 人开始时间: 2018年11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
- 3
研究概览
简要总结
Of the three cases in which the study was performed, one died (no causal relationship to the study device), one was discontinued, and one was completed at 6 months. None of the patients had DL infection, which is considered a major complication of implantable ventricular assisted device.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) patient who understands the purpose of the study and consents the entry.
- •2) 20 years old or older.
- •3) patient and his family understand and consent end-of-life care.
- •4) severe heart failure patient who needs heart transplantation but is ineligible for it.
- •5) New York Heart Association Class IIIb and IV end-stage left ventricular failure.
- •6) patient who has undergone maximum optimal medical therapy but has been demonstrated to be refractory to it.
- •7) BSA 1.2-2.3m2
- •8)patient who has a care-giver.
排除标准
- •1) J-macs profile 1
- •2) patients who have uncontrollable severe infections.
- •3) the prognosis of other diseases is less than 3 years.
- •4) patients who underwent open chest surgery less than 2 weeks before.
- •5) patients who has contraindication of LVAD implantation due to aortic or ventricular aneurysm, or VSD etc(exclude the cases who can undergo the surgery at the same time).
- •6) patients who has moderate AR (exclude the cases who can undergo the surgery at the same time).
- •7) patients with severe cerebral or phsychological disease who can't control LVAD.
- •8) patients who has a tendency to bleed.
- •9) pregnant or who wants to became pregnant
- •10)cirrhosis (Child C)
- •11) patients who refuse transfusion.
- •12) patients who has an allergy to bovine products.
- •13) patients who are participating other clinical studies which affects this study.
- •14) patients who are considered to be inappropriate
- •to join this study by the researcher.
- •15) Patients who can participate in other clinical trials of DT at the time of registration in this study.
- •16) Patients who are predicted to have difficulty discharging due to right ventricular function and severe heart failure after surgery.
- •17) Patients who have active inflammatory disease with a history of oral administration of steroids more than 1month within 1 year, or with a current use of steroids. Otherwise, patients whose general condition is severely impaired by systemic wasting disease except for heart failure.
研究者
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