UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003665 |
|---|---|
| Receipt number | R000004439 |
| Scientific Title | The development of the treatment for heart failure using non-pulsatile Left ventricle assist device |
| Date of disclosure of the study information | 2010/05/25 |
| Last modified on | 2018/09/18 14:54:01 |
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Basic information
Public title
The development of the treatment for heart failure using non-pulsatile Left ventricle assist device
Acronym
The development of the treatment for heart failure using non-pulsatile Left ventricle assist device
Scientific Title
The development of the treatment for heart failure using non-pulsatile Left ventricle assist device
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Sawa Yoshiki |
Organization
Osaka University Graduate School of Medicine
Division name
The department of Cardiovascular Surgery
Zip code
Address
Yamadaoka 2-2 Suitasi Osaka Japan
TEL
06-6879-3154
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate School of Medicine
Division name
The department of Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Medical Center for Translational Research, Osaka University Hospital
Institute
Department
Personal name
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)
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
| 2010 | Year | 05 | Month | 25 | 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
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004439
