UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023403 |
|---|---|
| Receipt number | R000025977 |
| Scientific Title | Additional ablation targeting low-voltage areas after durable pulmonary vein isolation in paroxysmal atrial fibrillation ablation |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2021/08/02 10:27:35 |
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Basic information
Public title
Additional ablation targeting low-voltage areas after durable pulmonary vein isolation in paroxysmal atrial fibrillation ablation
Acronym
VOLCANO AF
Scientific Title
Additional ablation targeting low-voltage areas after durable pulmonary vein isolation in paroxysmal atrial fibrillation ablation
Scientific Title:Acronym
VOLCANO AF
Region
| Japan |
Condition
Condition
paroxysmal atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the AF recurrence rate between 3 groups: (1)patients with low-voltage zone and undergo PVI and low-voltage guided ablation, (2) patients with low-voltage zone and undergo PVI only, and (3) patients without low-volatge zone
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AF recurrence 1 year after the initial procedure
Key secondary outcomes
AF recurrence 1 year after the multiple procedure
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
PVI and low-voltage guided ablation in patients with low-voltage zone
Interventions/Control_2
PVI in patients with low-voltage zone
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing the inital ablation for paroxysmal AF
Key exclusion criteria
Cardiac surgery, Heart failure symptoms
Target sample size
300
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
TEL
660-0066
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
TEL
0664161221
Homepage URL
masuda101@gmail.com
Sponsor or person
Institute
Cardiovascular center, Kansai Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 09 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 21 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2021 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025977
