UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The development of the treatment for heart failure using non-pulsatile Left ventricle assist device
Title of the study (Brief title)	The development of the treatment for heart failure using non-pulsatile Left ventricle assist device
Region	Japan

Condition
Condition	End-staged dilated cardiomyopathy and ischemic cardiomyopathy who receive Left ventricle assist devise
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will reimplant extra-corponeal left ventricle assit devise to implantable left ventricle assist devise in heart failure patiets who must stay in hospital for a long time. We will analyse whether patients who received implantable left ventricle assisit devise could wait for heart transplantation at home with better quality of life.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We will analyse the survival curve and complication rate after the reimplantation of implantable left ventricle assist devise.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	15 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	(a) Severe heart failure patient whosesymptoms is NYHA 4 after treatment of maximum medication and surgical procedure. (b) Applicable age is over 15 years old and under 75 years old (c) Informed concent
Key exclusion criteria	(a) Malingant cancer (b)Pregnancy (c)Patients who is unsuitable for this clinical protocol (by doctor's decision)
Target sample size	10

Research contact person
Name of lead principal investigator	Sawa Yoshiki
Organization	Osaka University Graduate School of Medicine
Division name	The department of Cardiovascular Surgery
Address	Yamadaoka 2-2 Suitasi Osaka Japan
TEL	06-6879-3154
Email

Public contact
Name of contact person
Organization	Osaka University Graduate School of Medicine
Division name	The department of Cardiovascular Surgery
Address
TEL
Homepage URL
Email

Sponsor
Institute	Medical Center for Translational Research, Osaka University Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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	2010 Year 05 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 01 Day
Anticipated trial start date	2009 Year 12 Month 25 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	This protocol is on going and some patients could go back home and are waiting for heart transplantation.

Management information
Registered date	2010 Year 05 Month 25 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004439