UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024668 |
|---|---|
| Receipt number | R000028374 |
| Scientific Title | Complex fractionated atrial electrocardiograms guided ablation versus pulmonary vein isolation guided ablation in persistent atrial fibrillation, a multicenter randomized trial |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2016/11/01 13:45:52 |
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Basic information
Public title
Complex fractionated atrial electrocardiograms guided ablation versus pulmonary vein isolation guided ablation in persistent atrial fibrillation, a multicenter randomized trial
Acronym
CIPA trial
Scientific Title
Complex fractionated atrial electrocardiograms guided ablation versus pulmonary vein isolation guided ablation in persistent atrial fibrillation, a multicenter randomized trial
Scientific Title:Acronym
CIPA trial
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
persistent atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare pulmonary vein isolation v.s. CFAE ablation in the patients with persistent atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
recurrence rate
Key secondary outcomes
procedure time, complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To randomize pulmonary vein isolation or CFAE ablation
Interventions/Control_2
18 months obsevation
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
persistent atrial fibrillation less than 1 year
Key exclusion criteria
left atrial dimension more than or equal 50 mm
Maintained sinus rhythm less than 30 sec
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Oketani |
Organization
Kagoshima university hospital
Division name
cardiovascular medicine
Zip code
Address
8-35-1 Sakuragaoka, kagoshima
TEL
099-275-5318
oketani@m.kkufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoya Oketani |
Organization
Kagoshima university hospital
Division name
cardiovascular medicine
Zip code
Address
8-35-1 Sakuragaoka, kagoshima
TEL
099-275-5318
Homepage URL
oketani@m.kkufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Isala, Zwolle, The Netherland
Institute
Department
Personal name
Funding Source
Organization
Johnson and johnson
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
The United States
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
54589.075.15
Org. issuing International ID_1
Isala
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
鹿児島大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | 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
| 2014 | Year | 11 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 11 | Month | 01 | Day |
Last modified on
| 2016 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028374
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
