臨床研究等提出・公開システム

Clinical research of the left ventricular assist device with post-auricular connector (Clinical research of the left ventricular assist device with post-auricular connector)

Clinical research of Jarvik-PA (Clinical research of Jarvik-PA)

3

dilated phase of hypertrophic cardiomyopathy:2 patients ischemic cardiomyopathy:1 patient

enrollment :3 patients implantation of Jarvik-PA:3 patients withdrawal:1 patient death:1 patient

none

There were no DL infections in the three patients treated in this study. 17 adverse events were observed, none of which were causally related to the study device. No rehospitalization or re-operation was performed in the three cases up to 6 months after implantation.

Of the three cases in which the study was performed, one died (no causal relationship to the study device), one was discontinued, and one was completed at 6 months. None of the patients had DL infection, which is considered a major complication of implantable ventricular assisted device.

April. 30, 2022

Yes

Thedeidentified individual subject data will be used for conference presentations, research articles,or both. If it is provided to the sponsor,it will be shared based on the agreement.

https://jrct.mhlw.go.jp/latest-detail/jRCTs052180006

Sawa Yoshiki

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka, Japan

sawasec@surg1.med.osaka-u.ac.jp

Kawamura Takuji

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka, Japan

+81-6-6879-3154

t-kawamura@surg1.med.osaka-u.ac.jp

Complete

Oct. 03, 2018

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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.

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.
15) Patients who can participate in other clinical trials of DT at the time of registration in this study.
16) Patients who are predicted to have difficulty discharging due to right ventricular function and severe heart failure after surgery.
17) Patients who have active inflammatory disease with a history of oral administration of steroids more than 1month within 1 year, or with a current use of steroids. Otherwise, patients whose general condition is severely impaired by systemic wasting disease except for heart failure.

Both

severe heart failure

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 cardiac transplantation.

Presence of Drive-Line infection and occurrence of adverse events up to 6 months after implantation.

1) Side effects during and after surgery
2) Assessment of stroke and survival at 6 months after implantation
1. Condition without occurrence of stroke with modified Rankin Scale> 3
2. Percentage of survival cases without reoperation for repair or replacement of LVAD
3. Percentage of survival cases
4. NIH stroke scale
3) Assessment of Heart failure
1. NYHA cardiac function classification
2. Evaluation of Specific Activity Scale
3. 6-minute walk test
4) QOL
1. EuroQOL (EQ - 5D - 5L)
2. MLHFQ
5) Psychological state (PHQ-9, satisfaction with treatment)

+81-6-6210-8296

Sept. 11, 2018

none