UMIN-CTR Clinical Trial

Basic information
Public title	Prognosis about stroke, systemic embolism, or dementia in patients with atrial fibrillation treated with and without ablation.
Acronym	Hyogo AF network (HAF-Net)
Scientific Title	Prognosis about stroke, systemic embolism, or dementia in patients with atrial fibrillation treated with and without ablation.
Scientific Title:Acronym	Hyogo AF network (HAF-Net)
Region	Japan

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

Objectives
Narrative objectives1	The Hyogo AF network is a prospective investigation in Hyogo prefecture in order to evaluate the prognosis about stroke, systemic embolism, or dementia in patients with atrial fibrillation treated with and without ablation.
Basic objectives2	Others
Basic objectives -Others	Registration and follow-up
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	stroke(including transient ischemic attack), systemic embolism, or major hemorrhage
Key secondary outcomes	dementia, cardiac hospitalization, and all cause death

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 documented on 12 lead electrocardiography
Key exclusion criteria	none
Target sample size	1800

Research contact person
Last name of lead principal investigator	1st name Akihiro Middle name Last name Yoshida
Organization	Kita-Hrima Medical Center
Division name	Department of Cardiology
Zip code	675-1392
Address	926-250 Ichiba-cho, Ono city, Hyogo
TEL	0794-88-8800
Email	ayoshida@kitahari-mc.jp

Public contact
1st name of contact person	1st name Kojiro Middle name Last name Fukuzawa
Organization	kobe university graduate school of medicine
Division name	division of cardiovascular medicine, department of internal medicine
Zip code	650-0017
Address	7-5-2 Kusunoki-cho, Chuou-ku, Kobe
TEL	078-382-5846
Homepage URL
Email	kojisoccer2002@yahoo.co.jp

Sponsor
Institute	kobe university graduate school of medicine
Institute
Department

Funding Source
Organization	kobe university graduate school of medicine
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	The Ethics Committee at Kobe university graduate school of medicine
Address	7-5-2 Kusunoki-cho, Chuou-ku, Kobe
Tel	078-382-6669
Email	kansatsu@med.kobe-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	2019 Year 05 Month 17 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	2168
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	No longer recruiting
Date of protocol fixation	2014 Year 10 Month 02 Day
Date of IRB	2014 Year 10 Month 02 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date	2022 Year 02 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	clinical outcome of patients with atrial fibrillation in Hyogo prefecture.

Management information
Registered date	2019 Year 05 Month 17 Day
Last modified on	2019 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019127