UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025211 |
|---|---|
| Receipt number | R000028998 |
| Scientific Title | Clinical research of the left ventricular assist device with post-auricular connector |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2016/12/10 11:16:18 |
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Basic information
Public title
Clinical research of the left ventricular assist device with post-auricular connector
Acronym
Clinical research of Jarvik-PA
Scientific Title
Clinical research of the left ventricular assist device with post-auricular connector
Scientific Title:Acronym
Clinical research of Jarvik-PA
Region
| Japan |
Condition
Condition
severe heart failure
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to evaluate the 6-month safety of the Jarvik 2000 Left Ventricular Assist System (LVAS) with Post-Auricular Connector, in patients with end-stage left ventricular failure who are ineligible for cardiac transplantation and have been demonstrated to be refractory to optimal medical therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Drive-line infection 6-month after the implantation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sawa |
Organization
Osaka University hospital
Division name
Department of Cardiovascular Surgery
Zip code
Address
2-15, Yamadaoka, Suita, Osaka
TEL
0668793154
sawa-p@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryohei Matsuura |
Organization
Osaka University hospital
Division name
Department of Cardiovascular Surgery
Zip code
Address
2-15, Yamadaoka, Suita, Osaka
TEL
0668793154
Homepage URL
r-matsuura@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 10 | Day |
Last modified on
| 2016 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028998
