Clinical study of Patient-Specific Cardiac Support Net for dilated cardiomyopathy.

Recruitment & Eligibility

Status: Complete: follow-up complete

Sex: All

Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with excessively enlarged heart(LVEDD>85mm) 2)Patients with extremely low LVEF(<10%) 3)Patients with history of cardiac surgeryexcept 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 (FEV-1 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 (cerebral infarction, cerebral hemorrhage, etc.) within 3 months 20)Patients with a high degree of bleeding tendency 21)Patients with blood clotting disorders (patients with contraindicated for antithrombotic treatment) 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
End Point; The evaluation of the safeness during 24 weeks after implantation of this device. New treatment added by heart failure exacerbation, and another performing of cardiac surgery. All-cause mortality, cardiac death.(death due to heart failure exacerbation) all adverse events. Device trouble.

Secondary Outcome Measures

Name	Time	Method

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