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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041033
Receipt No. R000046607
Scientific Title Relationship between recurrence and exposure in catheter ablation of atrial fibrillation
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/08

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Basic information
Public title Relationship between recurrence and exposure in catheter ablation of atrial fibrillation
Acronym AF ablation and exposure
Scientific Title Relationship between recurrence and exposure in catheter ablation of atrial fibrillation
Scientific Title:Acronym AF ablation and exposure
Region
Japan

Condition
Condition Atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigation the recurrence, exposure and safety rate of patients underwent catheter ablation of atrial fibrillation between the contrast CT and the non-contrast CT group.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint was the recurrence of AF or other atrial tachy-arrhythmia. Observational period was set at 2 year after the index ablation.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Contrast CT group
Interventions/Control_2 Non contrast CT group
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 AF patients with indication for catheter ablation by Japanese Circulation Society guideline.
Key exclusion criteria Renal dysfunction or allergy of contrast
BNP > 1000 pg/ml
Left atrium diameter > 55mm
Target sample size 340

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Oikawa
Organization Kitasato University School of Medicine
Division name Cardiovascular medicine
Zip code 2520374
Address Minamiku Kitasato 1-15-1, Sagamihara
TEL 042427788111
Email joichan@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name Oikawa
Organization Kitasato University School of Medicine
Division name Cardiovascular Medicine
Zip code 2520374
Address Minamiku Kitasato 1-15-1, Sagamihara
TEL 0427788111
Homepage URL
Email joichan@med.kitasato-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kitasato University School of Medicine.
Institute
Department

Funding Source
Organization None
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 The Ethics Committee of Kitasato University hospital
Address Minamiku Kitasato 1-15-1, Sagamihara
Tel 0427788111
Email rinrib@med.kitasato-u.ac.jp

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
2020 Year 08 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 08 Day
Last modified on
2020 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046607

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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