UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026849 |
|---|---|
| Receipt number | R000030813 |
| Scientific Title | Atrial Fibrillation registry to Follow the long-teRm Outcomes and the use of aNTIcoagulants aftER Ablation |
| Date of disclosure of the study information | 2017/04/04 |
| Last modified on | 2023/11/23 08:39:12 |
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Basic information
Public title
Atrial Fibrillation registry to Follow the long-teRm Outcomes and the use of aNTIcoagulants aftER Ablation
Acronym
AF Frontier Ablation Registry
Scientific Title
Atrial Fibrillation registry to Follow the long-teRm Outcomes and the use of aNTIcoagulants aftER Ablation
Scientific Title:Acronym
AF Frontier Ablation Registry
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the long-term risks of strokes and cardiovascular events after atrial fibrillation ablation
To investigate the discontinuation of anticoagulant drugs in the chronic phase after atrial fibrillation ablation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism
Key secondary outcomes
Discontinuation of anticoagulant drugs
Atrial fibrillation recurrence after the blanking period
Major adverse cardiac events (myocardial infarction/unstable angina pectoris and heart failure)
All cause of death
Major bleeding(adapeted ISTH standard)
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent atrial fibrillation ablation before January 1, 2012, and were followed-up at least 1 year after the ablation.
Key exclusion criteria
1) Patients contraindicated for direct oral anticoagulants
2) Patients who had acute myocardial infartion or stroke/TIA within 2 months before ablation
3) Patients judged as inappropriate for this study by investigators
Target sample size
3400
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Division name
Nihon University Itabashi Hospital
Zip code
173
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo
TEL
+81-3-3972-8111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Okumura |
| Middle name | |
| Last name | Yasuo |
Organization
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Division name
Nihon University Itabashi Hospital
Zip code
173
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo
TEL
+81-3-3972-8111
Homepage URL
okumura.yasuo@nihon-u.ac.jp
Sponsor or person
Institute
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ihon University Itabashi Hospital, Clinical Research Center
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
Tel
03(3972)8111
komoda.nozomi@nihon-u.ac.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 | 04 | Month | 04 | 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
2800 patients were enrolled.
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 01 | Day |
Other
Other related information
Retrospective observation study
Management information
Registered date
| 2017 | Year | 04 | Month | 03 | Day |
Last modified on
| 2023 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030813
