UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020644 |
|---|---|
| Receipt number | R000023826 |
| Scientific Title | A cohort single-center evaluation of efficacy and safety of cardiac rhythm device for bradycardia and tachycardia |
| Date of disclosure of the study information | 2016/01/19 |
| Last modified on | 2020/07/22 13:30:57 |
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Basic information
Public title
A cohort single-center evaluation of efficacy and safety of cardiac rhythm device for bradycardia and tachycardia
Acronym
the efficacy and safety of cardiac rhythm device for arrhythmia
Scientific Title
A cohort single-center evaluation of efficacy and safety of cardiac rhythm device for bradycardia and tachycardia
Scientific Title:Acronym
the efficacy and safety of cardiac rhythm device for arrhythmia
Region
| Japan |
Condition
Condition
bradycardia and tachycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of efficacy and safety of cardiac rhythm device for bradycardia and tachycardia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prognosis
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
The patient with cardiac rhythm device implantation.
Key exclusion criteria
none
Target sample size
7500
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Kusano |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibeshinmachi, Suita, Osaka
TEL
0661701070
kusanokengo@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Ishibashi |
Organization
National cerebral and cardiovascular center
Division name
Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibeshinmachi, Suita, Osaka
TEL
0661701070
Homepage URL
hgqcg618@ybb.ne.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
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
National Cerebral and Cardiovascular Center
Address
6-1 Kishibeshinmachi, Suita, Osaka
Tel
0661701070
rec-office-ac@ncvc.go.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
| 2016 | Year | 01 | Month | 19 | 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
7500
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
| 2016 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prognosis
Management information
Registered date
| 2016 | Year | 01 | Month | 19 | Day |
Last modified on
| 2020 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023826
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
