UMIN-CTR Clinical Trial

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	2017 Year 01 Month 16 Day
Anticipated trial start date	2017 Year 02 Month 13 Day
Last follow-up date	2019 Year 06 Month 30 Day
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	2020 Year 02 Month 13 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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