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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008546
Receipt No. R000010044
Scientific Title Upper gastrointestinal injury with catheter ablation of pulmonary isolation
Date of disclosure of the study information 2012/07/26
Last modified on 2016/07/29

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Basic information
Public title Upper gastrointestinal injury with catheter ablation of pulmonary isolation
Acronym Upper gastrointestinal injury with catheter ablation of pulmonary isolation
Scientific Title Upper gastrointestinal injury with catheter ablation of pulmonary isolation
Scientific Title:Acronym Upper gastrointestinal injury with catheter ablation of pulmonary isolation
Region
Japan

Condition
Condition Atrial Fibrillation
Classification by specialty
Gastroenterology Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the injury of esophagus and paraesophageal nerve with catheter ablation of pulmonary isolation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Upper gastrointestinal injury after ablation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Food Device,equipment
Interventions/Control_1 Isotope breath tests(within a month before ablation,within a week after ablation,2 to 6 months after ablation)
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 Patient who is planing to receive treatment of pulmonary vein isolation
Key exclusion criteria Patient who isn't got informed consent
Patient whom doctor considers inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Kobayashi
Organization Chiba University graduate school of medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-8-1,inohana,chuou-ku,chiba-shi,chiba prefecture
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University graduate school of medicine
Division name Department of Cardiovascular Medicine
Zip code
Address
TEL 043-226-2555
Homepage URL
Email

Sponsor
Institute Chiba University graduate school of medicine
Institute
Department

Funding Source
Organization St.Jude Medical
Organization
Division
Category of Funding Organization Outside Japan
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 07 Month 26 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 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2016 Year 05 Month 31 Day
Date of closure to data entry
2016 Year 05 Month 31 Day
Date trial data considered complete
2016 Year 05 Month 31 Day
Date analysis concluded
2016 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 26 Day
Last modified on
2016 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010044

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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