UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Complex fractionated atrial electrocardiograms guided ablation versus pulmonary vein isolation guided ablation in persistent atrial fibrillation, a multicenter randomized trial
Title of the study (Brief title)	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	Naoya Oketani
Organization	Kagoshima university hospital
Division name	cardiovascular medicine
Address	8-35-1 Sakuragaoka, kagoshima
TEL	099-275-5318
Email	oketani@m.kkufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Naoya Oketani
Organization	Kagoshima university hospital
Division name	cardiovascular medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 11 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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