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临床试验/JPRN-jRCT2042210157
JPRN-jRCT2042210157招募中2 期

Investigator-initiated clinical trial of Patient-Specific Cardiac Support Net for dilated cardiomyopathy

Akita Toshiaki0 个研究点目标入组 5 人开始时间: 2022年3月6日最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
5
研究概览入排标准研究者记录与标识符相似试验

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 at the time of obtaining informed consent
  • •4) Patients whom NYHA classification is IIm, 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 with Peak VO2 between 7 to 16 mL/kg/min in cardiopulmonary exercise testing .
  • •8) Patients who can undergo cardiac MRI or contrast-enhanced cardiac CT and cardiac catheterization to manufacture clinical trial equipment
  • •9) 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 90 mm in echocardiography
  • •2) Patients with extremely low LVEF less than 10% in echocardiography
  • •3) Patients who are scheduled for other combined cardiac surgery like mitral valve replacement, mitral valve formation, tricuspid valve formation
  • •4) Patients with history of cardiac surgery except patients with pericardial effusion and mild adhesions
  • •around the heart or patients 3 months after pacemaker treatment with intravenous leads (ICD, CRT-P, CRT-D).
  • •5)Patients undergoing treatment with other cardiac treatment devices such as IABP and ECMO or planning other cardiac surgery
  • •6) Patients who have developed acute myocardial infarction, unstable angina within 3 months or patients
  • •who have undergone PCI or transmyocardial laser revascularization or their candidate patients
  • •7) Patients with NYHA classification IV and who are adapted to left ventricular assist devices or candidate
  • •for heart transplant
  • •8) Patients with dilated phase hypertrophic cardiomyopathy
  • •9) Patient with active infection
  • •10) Patients with history of cerebrovascular disease within 3 months of obtaining consent
  • •11) Patients with blood clotting disorders or patients who refuse blood transfusion
  • •12) Patients with poor prognosis by malignant diseases
  • •13) Patients with severe dementia, drug addiction, alcoholism
  • •14)Patients with severe allergy
  • •15) Pregnant or nursing patients. Patients who do not agree with contraception during the study
  • •16) Patients participating in other interventional studies
  • •17) Patients whom the investigator determine unsuitable for participation

研究者

发起方
Akita Toshiaki

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