UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040363 |
|---|---|
| Receipt number | R000046007 |
| Scientific Title | Concealed connection between pulmonary veins and atrium after pulmonary vein antrum isolation in patients with atrial fibrillation |
| Date of disclosure of the study information | 2020/05/11 |
| Last modified on | 2022/10/25 05:52:21 |
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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
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
matakemo@kc4.so-net.ne.jp
Sponsor or person
Institute
Steel Memorial Yawata Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046007
