UMIN-CTR Clinical Trial

Basic information
Public title	Kansai Plus Atrial Fibrillation registry
Acronym	KPAF registry
Scientific Title	Kansai Plus Atrial Fibrillation registry
Scientific Title:Acronym	KPAF registry
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study was to evaluate short- and long-term outcomes of catheter ablation for atrial fibrillation in a real world population of Japanese patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Long-term event free rates from atrial tachyarrhythmia and major cardiovascular events including death, stroke or systemic thromboembolism, and heart failure after catheter ablation for atrial fibrillation.
Key secondary outcomes

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	10 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing first radiofrequency catheter ablation for atrial fibrillation.
Key exclusion criteria	Patients unwilling to sign the consent form for participation.
Target sample size	5010

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Shizuta
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	606-8507
Address	54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-4255
Email	shizuta@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Shizuta
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	606-8507
Address	54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-4255
Homepage URL
Email	shizuta@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Research Institute for Production Development
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-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	2011 Year 08 Month 02 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	5010
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	2011 Year 07 Month 30 Day
Date of IRB	2011 Year 10 Month 06 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a multicenter registry of patients undergoing radiofrequency catheter ablation for atrial fibrillation. From 26 centers, mostly located in Kasai area of Japan, 5010 patients were finally enrolled in the study.

Management information
Registered date	2011 Year 08 Month 02 Day
Last modified on	2022 Year 05 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007214