Dilated cardiomyopathy
Conditions
Interventions
Sponsors
Nagoya University School of Medicine
Osaka University Hospital, Tohoku University Hospital, Jikei University,Nagago unversity
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 (ACEI, ARB, diuretics, beta-blockers,oral cardiotonic, etc.) 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 >= 60mm or LVEDDi >= 30mm/m2 in echocardiography 6) Patients with LVEF <= 35% in echocardiography 7) Patients with RVEDVi <= 170mL/m2 by MRI or CT analysis 8) Patients with walking distance of 6 minutes <= 450m 9) Patients who have the intention of follow-up examination and observation, and can be admitted to visit the hospital which carries out them
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactToshiaki Akita
Nagoya University School of Medicine Cardiac Surgery
Outcome results
None listed