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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026849
Receipt No. 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 2018/05/07

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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
Middle name
Last name Yasuo Okumura
Organization Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Division name Nihon University Itabashi Hospital
Zip code
Address 30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL +81-3-3972-8111
Email okumura.yasuo@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Okumura
Organization Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Division name Nihon University Itabashi Hospital
Zip code
Address 30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL +81-3-3972-8111
Homepage URL
Email okumura.yasuo@nihon-u.ac.jp

Sponsor
Institute Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department

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
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

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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective observation study

Management information
Registered date
2017 Year 04 Month 03 Day
Last modified on
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030813

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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