UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055562 |
|---|---|
| Receipt number | R000051190 |
| Scientific Title | Multi center observational study of catheter ablation therapy |
| Date of disclosure of the study information | 2024/09/20 |
| Last modified on | 2025/09/22 07:49:06 |
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Basic information
Public title
Prospective survey of catheter ablation cases in Nagano Prefecture and Shinshu University-related hospitals
Acronym
Shinshu-AB Registry
Scientific Title
Multi center observational study of catheter ablation therapy
Scientific Title:Acronym
Catheter ablation registry
Region
| Japan |
Condition
Condition
Arrythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understand the current status of ablation treatment (facility, disease classification, treatment method, tools used, success rate, and complications) in Nagano Prefecture and Shinshu University-related hospitals, especially of elderly people, who are among the longest-lived in Japan. The objective is to clarify the efficacy, safety, risk, and disease regionality of ablation treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The follow-up period is one year after from the start of registration or until death. Evaluations are performed at 2 years and 3 years after treatment by outpatient or telephone interviews.
Follow-up is on the safety and efficacy of treatment.
Key secondary outcomes
Confirmation of adverse events
Presence or absence of recurrence
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
All patients receiving catheter ablation treatment at participating facilities are included.
Patients who meet all of the following criteria are targeted:
1. Patients visiting or hospitalized in the cardiology department of a participating facility.
2. Patients diagnosed as having arrhythmia and undergoing catheter ablation.
3. Consent to follow-up after ablation treatment.
Key exclusion criteria
Refusal to participate in the research.
Target sample size
7500
Research contact person
Name of lead principal investigator
| 1st name | Okada |
| Middle name | |
| Last name | Ayako |
Organization
Shinshu University Hospital
Division name
Cardiovascular medicine
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
+81263373352
aokada@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kobayashi |
| Middle name | |
| Last name | Hideki |
Organization
Shinshu University Hospital
Division name
Cardiovascular medicine
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
+81263373352
Homepage URL
kobayashih@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university hospital
Institute
Department
Personal name
Funding Source
Organization
Shinshu university hospital
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
Shinshu University IRB
Address
3-1-1, Asahi, Matsumoto, Nagano
Tel
+81263372572
Md_rinri@shinshu-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
上越総合病院
長野市民病院
長野中央病院
長野赤十字病院
信州上田医療センター
佐久医療センター
浅間南麓こもろ医療センター
北アルプス医療センターあづみ病院
松本協立病院
相澤病院
諏訪赤十字病院
伊那中央病院
飯田市立病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 20 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-center study
Non-intervention
Observational study
Management information
Registered date
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051190
