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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041762
Receipt No. R000047408
Scientific Title A single-center prospective/retrospective registry database of patients with atrial fibrillation aiming to identify clinically applicable biomarkers
Date of disclosure of the study information 2020/09/14
Last modified on 2020/09/14

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Basic information
Public title A single-center prospective/retrospective registry database of patients with atrial fibrillation aiming to identify clinically applicable biomarkers
Acronym J-AF registry database (Juntendo-atrial fibrillation registry database)
Scientific Title A single-center prospective/retrospective registry database of patients with atrial fibrillation aiming to identify clinically applicable biomarkers
Scientific Title:Acronym J-AF registry database (Juntendo-atrial fibrillation registry database)
Region
Japan

Condition
Condition Atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To construct a prospective/retrospective registry database of patients with atrial fibrillation (AF) in Juntendo University Hospital
Basic objectives2 Others
Basic objectives -Others To identify clinical factors and clinically applicable biomarkers which associate with the pathogenesis and prognosis of AF
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence of AF within 1-year following catheter ablation
Key secondary outcomes Ischemic stroke, systemic arterial embolism, cardiovascular death, all-cause mortality within 1-year following catheter ablation

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with atrial fibrillation undergoing/underwent catheter ablation
Key exclusion criteria The patients who denied to enroll in this study.
The patients who decided to withdrew from this study.
The patients that one of the our investigators concluded that exclusion from this study is suitable.
Target sample size 2077

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Iwata
Organization Juntendo University Hospital
Division name Department of Cardiovascular Biology and Medicine
Zip code 113-8431
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL +81-3-3813-3111
Email h-iwata@juntendo.ac.jp

Public contact
Name of contact person
1st name Kai
Middle name
Last name Ishii
Organization Juntendo University Hospital
Division name Department of Cardiovascular Biology and Medicine
Zip code 113-8431
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL +81-3-3813-3111
Homepage URL
Email ka.ishii@juntendo.ac.jp

Sponsor
Institute Juntendo University Hospital
Department of Cardiovascular Biology and Medicine
Institute
Department

Funding Source
Organization Juntendo University
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 Juntendo Clinical Research and Trial Center
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel +81-3-3814-5672
Email kenkyu5858@juntendo.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 順天堂大学医学部付属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 14 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
2020 Year 09 Month 14 Day
Date of IRB
2020 Year 07 Month 31 Day
Anticipated trial start date
2020 Year 09 Month 14 Day
Last follow-up date
2024 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The prospective part of the study has started on July 30th, 2020. Blood samples are obtained just before the procedure, and at 3, 6, 12 months after the catheter ablation and stocked at -30 degree.
The retrospective part of the study subjects 877 patients who underwent catheter ablation at Juntendo University Hospital from July 1st, 2017 to July 30th, 2020. Clinical information including patients demographics, complications, the status of AF, medications, findings of the electrocardiogram, echocardiography, devices used for catheter ablation, prognosis.

Management information
Registered date
2020 Year 09 Month 11 Day
Last modified on
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047408

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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