UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical research of the left ventricular assist device with post-auricular connector
Title of the study (Brief title)	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	Yoshiki Sawa
Organization	Osaka University hospital
Division name	Department of Cardiovascular Surgery
Address	2-15, Yamadaoka, Suita, Osaka
TEL	0668793154
Email	sawa-p@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person	Ryohei Matsuura
Organization	Osaka University hospital
Division name	Department of Cardiovascular Surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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