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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025211
Receipt No. 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

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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
Email 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
Email r-matsuura@surg1.med.osaka-u.ac.jp

Sponsor
Institute Osaka University hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028998

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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