severe heart failure
Conditions
Interventions
The study will utilize the Jarvik 2000 LVAS with Post- Auricular Connector in patients with New York Heart Association Class IIIb and IV end-stage left ventricular failure who are ineligible for cardi
Sponsors
Osaka University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drive-line infection 6-month after the implantation | — |
Countries
Japan
Contacts
Public ContactRyohei Matsuura
Osaka University hospital Department of Cardiovascular Surgery
Outcome results
None listed