Clinical research of Jarvik-PA

JRCT ID: jRCTs052180006

Registered date:01/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: severe heart failure
• Date of first enrollment: 03/10/2018
• Target sample size: 6
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

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

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.
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.

Related Information

• Primary Sponsor: Sawa Yoshiki
• Source(s) of Monetary Support: funding from patient
• Secondary ID(s): UMIN000025211