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UMIN-CTR Clinical Trial |
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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 | 2020/02/13 |
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 |
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Condition | ||
Condition | Non-Valvular Atrial Fibrillation | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 3000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
akihiko-ind@umin.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |