UMIN-CTR Clinical Trial

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