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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name