UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047063 |
|---|---|
| Receipt number | R000053692 |
| Scientific Title | Tokyo Medical and Dental University (TMDU) Ablation registry |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/03/03 15:22:56 |
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Basic information
Public title
Tokyo Medical and Dental University (TMDU) Ablation registry
Acronym
TMDU ablation registry
Scientific Title
Tokyo Medical and Dental University (TMDU) Ablation registry
Scientific Title:Acronym
TMDU ablation registry
Region
| Japan |
Condition
Condition
Arrhythmias requiring catheter ablation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the real-world efficacy, safety, and clinical outcomes of catheter ablation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Periprocedural complications
Arrhythmia recurrence
Clinical outcomes
Key secondary outcomes
Procedural findings
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 who underwent catheter ablation for clinical arrhythmias
Key exclusion criteria
Patients who refused to consent
Target sample size
25000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Sasano |
Organization
Tokyo Medical and Dental University
Division name
Department of cardiovascular medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5205
sasano.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Miyazaki |
Organization
Tokyo Medical and Dental University
Division name
Department of cardiovascular medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5231
Homepage URL
mshicvm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental 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
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
syomu1.adm@tmd.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
AOI国際病院(神奈川県)、青梅市立総合病院(東京都)、柏市立柏病院(千葉県)、亀田総合病院(千葉県)、国立病院機構災害医療センター(東京)、さいたま赤十字病院(埼玉県)、榊原記念病院(東京都)、JAとりで総合医療センター(茨城県)、静岡市立清水病院(静岡県)、新百合ヶ丘総合病院(神奈川県)、草加市立病院(埼玉県)、総合病院土浦協同病院(茨城県)、東京医科歯科大学病院(東京)、東京都立豊島病院(東京都)、東京都立広尾病院(東京)、東京山手メディカルセンター(東京都)、平塚共済病院(神奈川県)、武蔵野赤十字病院(東京都)、横須賀共済病院(神奈川県)、横浜市立みなと赤十字病院(神奈川県)、横浜南共済病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | 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
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 11 | Month | 08 | 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
| 2022 | Year | 03 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053692
