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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026092
Receipt No. R000029983
Scientific Title Real world ablation therapy with anticoagulants in management of atrial fibrillation
Date of disclosure of the study information 2017/02/10
Last modified on 2018/05/22

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Basic information
Public title Real world ablation therapy with anticoagulants in management of atrial fibrillation
Acronym RYOUMA Registry
Scientific Title Real world ablation therapy with anticoagulants in management of atrial fibrillation
Scientific Title:Acronym RYOUMA Registry
Region
Japan

Condition
Condition Non-Valvular Atrial Fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will be conducted to investigate real world anticoagulant therapy and its outcomes in patients receiving catheter ablation for NVAF and to separately assess the usefulness of oral anticoagulants in populations of patients receiving RF, CB, or HB ablation.
In addition, global assessment will be performed to find the most suitable target patient populations and the optimal regimen for edoxaban.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The overall incidence of adverse events during the follow-up period.
Key secondary outcomes

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 meet all of the following criteria at the time of giving informed consent are eligible as subjects of
this study.
(1) Patients with a diagnosis of NVAF.
(2) Patients scheduled to undergo catheter ablation
Key exclusion criteria Patients who meet any of the following criteria will be excluded from this study.
(1) It is impossible to obtain written informed consent from the patient or a legal representative.
(2) Current or scheduled participation in a clinical trial involving pharmacotherapy
(3) Not the first catheter ablation
(3) Any other reason that disqualifies the patient from participating in this study in the investigator's opinion
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Nogami
Organization Faculty of Medicune, University of Tsukuba
Division name Cardiovascular Division (Arrhythmia)
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575 Japan
TEL 029-853-3142
Email akihiko-ind@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazushuge Oishi
Organization Mediscience Planning Inc.
Division name Medical Information Div.
Zip code
Address 1-2-1 Nihonbashihamacho, Chuo-ku, Tokyo, 103-0007 Japan
TEL 03-5820-7026
Homepage URL
Email info-ryouma@mpi-cro.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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 筑波大学附属病院(茨城県)、他68施設

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 10 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
2017 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Major observation items to be examined for the relationship with primary and secondary outcomes are: patient background, CHASD2 score, CH2DS2-Vasc score, blood test, type of catheter ablation, use of drug (antiarrhythmic, anticoagulant, antiplatelet)

Management information
Registered date
2017 Year 02 Month 10 Day
Last modified on
2018 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029983

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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