UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028288
Receipt number R000032374
Scientific Title Japanese Cather Ablation (J-AB) Registry 2022
Date of disclosure of the study information 2017/07/19
Last modified on 2023/10/19 16:45:02

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Basic information

Public title

Japanese Cather Ablation (J-AB) Registry 2022

Acronym

J-AB registry 2022

Scientific Title

Japanese Cather Ablation (J-AB) Registry 2022

Scientific Title:Acronym

J-AB registry 2022

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


Not applicable

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 Kengo
Middle name
Last name Kusano

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Cardiovascular Medicine

Zip code

564-8565

Address

6-1Kishibeshim-machi, Suita-shi, Osaka

TEL

06-6170-1070

Email

kusanokengo@ncvc.go.jp


Public contact

Name of contact person

1st name Kengo
Middle name
Last name Kusano

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Cardiovascular Medicine

Zip code

564-8565

Address

6-1Kishibeshim-machi, Suita-shi, Osaka

TEL

06-6170-1070

Homepage URL

https://new.jhrs.or.jp/contents_web/j-ab/

Email

kusanokengo@ncvc.go.jp


Sponsor or person

Institute

National Cerebral and Cardiovascular Center

Institute

Department

Personal name



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

Japanese Heart Rhythm Society

Address

NF kudan-2, 4-2-28, Kudankita, Chiyoda-ku, Tokyo

Tel

03-6261-7351

Email

office@jhrs.or.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

2017 Year 07 Month 19 Day


Related information

URL releasing protocol

https://onlinelibrary.wiley.com/doi/full/10.1002/joa3.12163

Publication of results

Partially published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/full/10.1002/joa3.12445

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

2020 Year 10 Month 16 Day

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

2016 Year 12 Month 16 Day

Anticipated trial start date

2016 Year 12 Month 21 Day

Last follow-up date

2027 Year 03 Month 31 Day

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

2023 Year 10 Month 19 Day



Link to view the page

Value
https://center6.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