UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015332
Receipt number R000017828
Scientific Title Efficacy of Durable Arrhythmogenic Pulmonary Vein Isolation on Initial Procedural Success in Patients Undergoing Atrial Fibrillation Ablation
Date of disclosure of the study information 2014/10/03
Last modified on 2016/07/29 23:32:50

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Basic information

Public title

Efficacy of Durable Arrhythmogenic Pulmonary Vein Isolation on Initial Procedural Success in Patients Undergoing Atrial Fibrillation Ablation

Acronym

DRAGON study

Scientific Title

Efficacy of Durable Arrhythmogenic Pulmonary Vein Isolation on Initial Procedural Success in Patients Undergoing Atrial Fibrillation Ablation

Scientific Title:Acronym

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

1st name
Middle name
Last name Masaharu Masuda

Organization

Kansai Rosai Hospital

Division name

Cardiovascular center

Zip code


Address

3-1-69, Inabaso, Amagasaki, Hyogo

TEL

06-6416-1221

Email

masuda101@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Masaharu Masuda

Organization

Kansai Rosai Hospital

Division name

Cardiovascular center

Zip code


Address

3-1-69, Inabaso, Amagasaki, Hyogo

TEL

06-6416-1221

Homepage URL


Email

masuda101@gmail.com


Sponsor or person

Institute

Kansai Rosai Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

No longer recruiting

Date of protocol fixation

2014 Year 09 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017828


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name