UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028093 |
|---|---|
| Receipt number | R000032167 |
| Scientific Title | Post-marketing research by HeartSheet patient registration system |
| Date of disclosure of the study information | 2017/07/07 |
| Last modified on | 2026/01/20 08:14:11 |
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Basic information
Public title
Post-marketing research by HeartSheet patient registration system
Acronym
HeartSheet patient registration system
Scientific Title
Post-marketing research by HeartSheet patient registration system
Scientific Title:Acronym
HeartSheet patient registration system
Region
| Japan |
Condition
Condition
Severe heart failure due to chronic ischemic heart disease
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Characteristics of patients registered in the Heart Seat Patient Registration System (Patient Registration System Regarding Patients Using Heart Sheet etc.), defects / adverse events occurring when using the Heart Sheet, post-marketing data related to the Heart Sheet In the long term and analyze the data to evaluate the effectiveness and safety of the heart sheet.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)adverse events
2)Device deficiencies
3) mortality
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who agreed to participate in this study, among the subjects of HeartSheet Use Results Survey (All Example Studies)
Key exclusion criteria
no reguiation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Senshu |
Organization
Terumo Corporation
Division name
Clinical Development Department
Zip code
163-1450
Address
Tokyo Opera City Tower 49F, 3-20-2, Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6742-8500
Rinshokenkyu_HS@terumo.co.jp
Public contact
Name of contact person
| 1st name | kazuo |
| Middle name | |
| Last name | tamada |
Organization
Terumo Corporation
Division name
Clinical Development Department
Zip code
163-1450
Address
Tokyo Opera City Tower 49F, 3-20-2, Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6742-8500
Homepage URL
Rinshokenkyu_HS@terumo.co.jp
Sponsor or person
Institute
Terumo Corporation
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Review Board
Address
1500, inokuchi,nakaimachi,ashigarakami-gun kanagawa, Japan
Tel
0465-81-4112
Hirokazu_Hasegawa@terumo.co.jp
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 | 07 | Month | 07 | 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
29
Results
Of the target patients, 29 cases consented to participate in this study. Data for 26 of these cases was transferred to the database for this study. (The data for the remaining 3 cases had not been fixed in the HeartSheet PMS, which was the subject of the study, at the end of this study, so they were not transferred to the database for this study.) Study results are currently being compiled.
Results date posted
| 2026 | Year | 01 | Month | 19 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Study results are currently being compiled.
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
| 2016 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 07 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032167
