UMIN-CTR Clinical Trial

Basic information
Public title	Concealed connection between pulmonary veins and atrium after pulmonary vein antrum isolation in patients with atrial fibrillation
Acronym	COCO-AF
Scientific Title	Concealed connection between pulmonary veins and atrium after pulmonary vein antrum isolation in patients with atrial fibrillation
Scientific Title:Acronym	COCO-AF
Region	Japan

Condition
Condition	Patients who undergo radio-frequency catheter ablation of atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) How frequency will be the concealed connection between pulmonary veins and atrium after pulmonary vein antrum isolation? 2) How will be the differences of frequency between paroxysmal, persistent, and long-lasting atrial fibrillation? 3) After treatment of these connections, will treatment results of atrial fibrillation be improved?
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	improvement of recurrence rate of atrial fibrillation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	catheter ablation of atrial fibrillation
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 who undergo radio-frequency catheter ablation of atrial fibrillation
Key exclusion criteria	nothing particular
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Masao Middle name Last name Takemoto
Organization	Steel Memorial Yawata Hospital
Division name	Cardiovascular Center
Zip code	8058508
Address	Kitakyushu
TEL	+81-93-672-3176
Email	matakemo@kc4.so-net.ne.jp

Public contact
Name of contact person	1st name Masao Middle name Last name Takemoto
Organization	Steel Memorial Yawata Hospital
Division name	Cardiovascular Center
Zip code	8058508
Address	Kitakyushu
TEL	+81-93-672-3176
Homepage URL
Email	matakemo@kc4.so-net.ne.jp

Sponsor
Institute	Steel Memorial Yawata Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Steel Memorial Yawata Hospital
Address	1-1-1 Harunomachi, Yahatahigashi-ku, Kitakyushu, Japan
Tel	+81-93-672-3176
Email	shimono.s@ns.yawata-mhp.or.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	2020 Year 05 Month 11 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/circj/86/8/86_CJ-22-0182/_article
Number of participants that the trial has enrolled	300
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	Completed
Date of protocol fixation	2019 Year 07 Month 01 Day
Date of IRB	2020 Year 05 Month 08 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 11 Day
Last modified on	2022 Year 10 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046007