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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046108
Receipt No. R000052619
Scientific Title Retrospective study of patients with implantable device
Date of disclosure of the study information 2021/11/22
Last modified on 2021/11/17

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Basic information
Public title Retrospective study of patients with implantable device
Acronym Retrospective study of patients with implantable device
Scientific Title Retrospective study of patients with implantable device
Scientific Title:Acronym Retrospective study of patients with implantable device
Region
Japan

Condition
Condition Arrhythmia, heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the prognosis of device-implanted patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Death, cardiovascular events
Key secondary outcomes Upgrade to implantable cardioverter defibrillator, cardiac resynchronization therapy

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who had an outpatient visit or hospitalization history to our department from January 1, 2006 to December 31, 2021 and had implantable devices (pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy) .
Key exclusion criteria none
Target sample size 2135

Research contact person
Name of lead principal investigator
1st name Kazuomi
Middle name
Last name Kario
Organization Jichi Medical University
Division name Division of cardiovascular medicine
Zip code 329-0498
Address 3311-1, Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7344
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Kabutoya
Organization Jichi Medical University
Division name Division of cardiovascular medicine
Zip code 329-0498
Address 3311-1, Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7344
Homepage URL
Email kabu@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Jichi Medical University
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 Jichi Medical University Clinical Research Ethics Committee
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, Japan
Tel 0285-58-8933
Email rinri@jichi.ac.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
2021 Year 11 Month 22 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 2135
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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 23 Day
Date of IRB
2018 Year 01 Month 23 Day
Anticipated trial start date
2018 Year 01 Month 23 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We retrospectively investigate patients who had an outpatient visit or hospitalization history to our department from January 1, 2006 to December 31, 2021 and had implantable devices (pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy) .
We examine the short-term and long-term outcomes of patients with implantable devices and the factors and prognosis that affect them.

Management information
Registered date
2021 Year 11 Month 18 Day
Last modified on
2021 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052619

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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