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

Completed

• Conditions: severe heart failure

• Registration Number: jRCTs052180006

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-01
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 6

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

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)
10. patients who refuse transfusion.
11. patients who has an allergy to bovine products.
12. patients who are participating other clinical studies which affects this study.
13. patients who are considered to be inappropriate
    to join this study by the researcher.
14. Patients who can participate in other clinical trials of DT at the time of registration in this study.
15. Patients who are predicted to have difficulty discharging due to right ventricular function and severe heart failure after surgery.
16. 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.

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Condition without occurrence of stroke with modified Rankin Scale> 3		Condition without occurrence of stroke with modified Rankin Scale> 3
Percentage of survival cases		Percentage of survival cases
Percentage of survival cases without reoperation for repair or replacement of LVAD		Percentage of survival cases without reoperation for repair or replacement of LVAD
NIH stroke scale		NIH stroke scale
NYHA cardiac function classification		NYHA cardiac function classification
Evaluation of Specific Activity Scale		Evaluation of Specific Activity Scale
6-minute walk test		6-minute walk test
EuroQOL (EQ - 5D - 5L)		EuroQOL (EQ - 5D - 5L)
MLHFQ		MLHFQ
Psychological state (PHQ-9, satisfaction with treatment)		Psychological state (PHQ-9, satisfaction with treatment)