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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
