UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Upper gastrointestinal injury with catheter ablation of pulmonary isolation
Title of the study (Brief title)	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	Yoshio Kobayashi
Organization	Chiba University graduate school of medicine
Division name	Department of Cardiovascular Medicine
Address	1-8-1,inohana,chuou-ku,chiba-shi,chiba prefecture
TEL
Email

Public contact
Name of contact person
Organization	Chiba University graduate school of medicine
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000010044