UMIN-CTR Clinical Trial

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

severe heart failure

Classification by specialty

Cardiology

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Drive-line infection 6-month after the implantation

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Osaka University hospital

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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