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Recruitment status
Unique ID issued by UMIN UMIN000023403
Receipt No. 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 2018/06/05

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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
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
TEL 0664161221
Homepage URL
Email masuda101@gmail.com

Sponsor
Institute Cardiovascular center, Kansai Rosai Hospital
Institute
Department

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
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
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
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
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
2018 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025977

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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