UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039258 |
|---|---|
| Receipt number | R000044390 |
| Scientific Title | Epidemiological study on the effectiveness and safety of catheter ablation: The Aomori Catheter Ablation Registry |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2023/01/28 12:30:11 |
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Basic information
Public title
Epidemiological study on the efficacy and safety of catheter ablation: The Aomori Catheter Ablation Registry
Acronym
The Aomori Catheter Ablation Registry
Scientific Title
Epidemiological study on the effectiveness and safety of catheter ablation: The Aomori Catheter Ablation Registry
Scientific Title:Acronym
The Aomori Catheter Ablation Registry
Region
| Japan |
Condition
Condition
Tachyarrhythmias
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the success rate, prognosis, and acute and chronic complications of catheter ablation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Freedom from tachyarrhythmias at 1 year after catheter ablation
Key secondary outcomes
Perioperative complications
Cardiovascular complications and death during follow-up
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 undergoing catheter ablation at Hirosaki University hospital and Aomori prefectural hospital
Key exclusion criteria
none
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Masaomi |
| Middle name | |
| Last name | Kimura |
Organization
Hirosaki University Graduate School of Medicine
Division name
Advanced Management of Cardiac Arrhythmias
Zip code
036-8216
Address
Zaifu-cho 5, Hirosaki City, Aomori, Japan
TEL
0172-33-5111
masaomi@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaomi |
| Middle name | |
| Last name | Kimura |
Organization
Hirosaki University Graduate School of Medicine
Division name
Advanced Management of Cardiac Arrhythmias
Zip code
036-8216
Address
Zaifu-cho 5, Hirosaki City, Aomori, Japan
TEL
0172-33-5111
Homepage URL
masaomi@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hirosaki University Hospital IRB
Address
Zaifu-cho 5, Hirosaki city, Aomori, Japan
Tel
0172-33-5111
rinri@hirosaki-u.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
| 2020 | Year | 02 | Month | 01 | 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
| 2020 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 01 | Month | 26 | Day |
Last modified on
| 2023 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044390
