UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046108 |
|---|---|
| Receipt number | R000052619 |
| Scientific Title | Retrospective study of patients with implantable device |
| Date of disclosure of the study information | 2021/11/22 |
| Last modified on | 2022/09/12 13:59:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 May 31, 2023 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 | 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
kabu@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
kabu@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University and MEDTRONIC JAPAN CO., LTD.
Organization
Division
Category of Funding Organization
Other
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
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
自治医科大学附属病院（栃木県）
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
Enrolling by invitation
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
| 2024 | Year | 08 | 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 May 31, 2023 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
| 2022 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052619
