UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Durable Arrhythmogenic Pulmonary Vein Isolation on Initial Procedural Success in Patients Undergoing Atrial Fibrillation Ablation
Title of the study (Brief title)	DRAGON study
Region	Japan

Condition
Condition	atrial fibriilation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of additional pulmonary vein antrum ablation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	recurrence of atrial fibrillation
Key secondary outcomes

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	extensive encircling pulmonary vein isolation
Interventions/Control_2	adding a segmental ablation line surrounding arrhythmogenic pulmonary vein
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 undergoing initial ablation for paroxysmal or persistent (duration < 1 year) atrial fibrillation
Key exclusion criteria	age < 20 years old, pregnancy, history of cardiac surgery, history of catheter ablation, significant valvular disease
Target sample size	168

Research contact person
Name of lead principal investigator	Masaharu Masuda
Organization	Kansai Rosai Hospital
Division name	Cardiovascular center
Address	3-1-69, Inabaso, Amagasaki, Hyogo
TEL	06-6416-1221
Email	masuda101@gmail.com

Public contact
Name of contact person	Masaharu Masuda
Organization	Kansai Rosai Hospital
Division name	Cardiovascular center
Address	3-1-69, Inabaso, Amagasaki, Hyogo
TEL	06-6416-1221
Homepage URL
Email	masuda101@gmail.com

Sponsor
Institute	Kansai Rosai Hospital
Institute
Department

Funding Source
Organization	Kansai Rosai Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

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	2014 Year 10 Month 03 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 03 Day
Last follow-up date	2016 Year 11 Month 01 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	2014 Year 10 Month 03 Day
Last modified on	2016 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017828