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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028288
Receipt No. R000032374
Scientific Title Japanese Cather Ablation (J-AB) Registry
Date of disclosure of the study information 2017/07/19
Last modified on 2018/10/31

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Basic information
Public title Japanese Cather Ablation (J-AB) Registry
Acronym J-AB registry
Scientific Title Japanese Cather Ablation (J-AB) Registry
Scientific Title:Acronym J-AB registry
Region
Japan

Condition
Condition Arrhythmias requiring catheter ablation therapy
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the real-world efficacy and safety of current ablation procedure in Japan
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes - In hospital early recurrence of targeted arrhythmia
Key secondary outcomes - In-hospital death (all-cause death, cardiovascular death, procedure-related death)
- Complication

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
0 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients treated with catheter ablation in Japan
Key exclusion criteria Patients who refused to consent
Target sample size 400000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kengo Kusano
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code
Address 5-7-1 Fujishirodai Suita-shi, Osaka
TEL 06-6833-5012
Email kusanokengo@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Kusano
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code
Address 5-7-1 Fujishirodai Suita-shi, Osaka
TEL 06-6833-5012
Homepage URL http://j-ab.ncvc.go.jp/
Email kusanokengo@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Japanese Heart Rhythm Society
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 07 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
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
2016 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study will start at Aug 1, 2017

Management information
Registered date
2017 Year 07 Month 19 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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