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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016638
Receipt No. R000019314
Scientific Title Impact of the cardiac sympathetic nerve function by atrial fibrillation catheter ablation
Date of disclosure of the study information 2015/02/25
Last modified on 2015/02/25

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Basic information
Public title Impact of the cardiac sympathetic nerve function by atrial fibrillation catheter ablation
Acronym Impact of the cardiac sympathetic nerve function by atrial fibrillation catheter ablation
Scientific Title Impact of the cardiac sympathetic nerve function by atrial fibrillation catheter ablation
Scientific Title:Acronym Impact of the cardiac sympathetic nerve function by atrial fibrillation catheter ablation
Region
Japan

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

Objectives
Narrative objectives1 To reveal the effects of pulmonary vein isolation on the autonomic nervous system using 123I-mIBG myocardial scintigraphy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sympathetic activity assessed by 123I-mIBG myocardial scintigraphy
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients underwent catheter ablation for atrial fibrillation
Key exclusion criteria patients taken beta blockade
patients with herat failure or reduced ejection fraction
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kanda
Organization Kansai Rosai Hospital
Division name Cardiovascular Center
Zip code
Address 3-1-69 Inabasou, Amagasaki
TEL 06-6416-1221
Email kanda-takashi@kanrou.net

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kanda
Organization Kansai Rosai Hospital
Division name Cardiovascular Center
Zip code
Address 3-1-69 Inabasou, Amagasaki
TEL 06-6416-1221
Homepage URL
Email kanda-takashi@kanrou.net

Sponsor
Institute Kansai Rosai Hospital
Institute
Department

Funding Source
Organization Kansai Rosai Hospital Cardiovascular Center
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 02 Month 25 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 Open public recruiting
Date of protocol fixation
2015 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2015 Year 02 Month 25 Day
Last modified on
2015 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019314

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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