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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028093
Receipt No. R000032167
Scientific Title Post-marketing research by HeartSheet patient registration system
Date of disclosure of the study information 2017/07/07
Last modified on 2019/07/11

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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
Email 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
Email Rinshokenkyu_HS@terumo.co.jp

Sponsor
Institute Terumo Corporation
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2020 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
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032167

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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