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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024668
Receipt No. 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

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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
Email 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
Email oketani@m.kkufm.kagoshima-u.ac.jp

Sponsor
Institute Isala, Zwolle, The Netherland
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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