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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009293
Receipt No. R000010913
Scientific Title Impact of atrial fibrillation ablation on cardiac sympathetic nurve system - Investigation using iodine-123 metaiodobenzylguanidine imaging
Date of disclosure of the study information 2012/11/08
Last modified on 2014/03/18

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Basic information
Public title Impact of atrial fibrillation ablation on cardiac sympathetic nurve system - Investigation using iodine-123 metaiodobenzylguanidine imaging
Acronym Impact of atrial fibrillation ablation on cardiac sympathetic nurve system - Investigation using iodine-123 metaiodobenzylguanidine imaging
Scientific Title Impact of atrial fibrillation ablation on cardiac sympathetic nurve system - Investigation using iodine-123 metaiodobenzylguanidine imaging
Scientific Title:Acronym Impact of atrial fibrillation ablation on cardiac sympathetic nurve system - Investigation using iodine-123 metaiodobenzylguanidine imaging
Region
Japan

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

Objectives
Narrative objectives1 To clarify the impact of atrial fibrillation ablation on cardiac sympathetic nurve activity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in H/M ratio and WR on Cardiac iodine-123 metaiodobenzylguanidine imaging before and after ablation
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 atrial fibrillation
Key exclusion criteria pregnancy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaharu Masuda
Organization Osaka University Hospital
Division name Cardiology
Zip code
Address Yamadaoka 2-15, Suita-shi, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka Universiy Hospital
Division name Division of Cardiology
Zip code
Address
TEL
Homepage URL
Email masuda101@cardiology.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate 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
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
2012 Year 11 Month 08 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
2012 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not registered

Management information
Registered date
2012 Year 11 Month 08 Day
Last modified on
2014 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010913

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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