jRCT2032250685招募中不适用
Confirmatory trialof Patient-Specific Cardiac Support Net for dilated cardiomyopathy
未提供0 个研究点目标入组 8 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
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
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Patients who sign the consent form of participating clinical study by their free will
- •Patients whose age are 18 years old or more, and 80 years or less at the time of obtaining informed consent
- •Patients whose heart failure symptoms persist despite receiving oral medication in accordance with the guidelines for the treatment of heart failure for more than three months at the time of consent, and whose symptoms are not expected to improve with the current treatment
- •Patients whom NYHA classification is IIm, III or IV A, or level of INTERMACS Profile is 4 to 7
- •Patients with LVEDD more than 60 mm or LVEDDi more than 30 mm/m2 in echocardiography
- •Patients with LVEF less than 40% (MR II or less) or LVEF 45% or less (MR III or more) in echocardiography
- •Patients who can undergo cardiac MRI or contrast-enhanced cardiac CT and cardiac catheterization to manufacture clinical trial equipment
- •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
- •Patients with excessively enlarged heart. LVEDD is more than 100 mm in echocardiography
- •Patients with extremely low LVEF less than 15% in echocardiography
- •Patients who are scheduled for other combined cardiac surgery like mitral valve replacement, mitral valve formation, tricuspid valve formation
- •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).
- •Patients undergoing treatment with other cardiac treatment devices such as IABP and ECMO or planning other cardiac surgery
- •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
- •Patients who required hospitalization for heart failure within one month prior to obtaining consent
- •Patients with NYHA classification IV and who are in heart transplant waiting list
- •Patients with dilated phase hypertrophic cardiomyopathy
- •Patient with active infection
- •Patients with history of cerebrovascular disease within 3 months of obtaining consent
- •Patients with blood clotting disorders or patients who refuse blood transfusion
- •Patients with poor prognosis by malignant diseases
- •Patients with severe dementia, drug addiction, alcoholism
- •Patients with severe allergy
- •Pregnant or nursing patients. Patients who do not agree with contraception during the study
- •Patients participating in other interventional studies
- •Patients whom the investigator determine unsuitable for participation
研究者
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