UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of Efficacy and Safety of esophageal monitoring catheters between with 3 thermocouples and with 5 thermocouples in patients with atrial fibrillation ablation.
Title of the study (Brief title)	AFabTC 3 vs. 5
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to evaluate safety Efficacy and Safety of esophageal monitoring catheters between with 3 thermocouples and with 5 thermocouples in patients with atrial fibrillation ablation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of moving an esophageal thermal catheter in atrial fibrillation ablation
Key secondary outcomes	Investigation of safety (nasal bleeding, bleeding of oral cavity, occurrence of esophageal thermal lesion) Chang in ablation lines in posterior wall of left atria Damage of esophageal and gastric vagal nerve Recurrence of atrial fibrillation 1 year after ablation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	esophageal monitoring catheters with 3 thermocouples
Interventions/Control_2	esophageal monitoring catheters with 5 thermocouples
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undertaken atrial fibrillation ablation using esophageal thermal monitoring and hospitalized in Showa university
Key exclusion criteria	Patients with cerebral infarction within one week before admission Patients with TIA within one week before admission Patients with systemic thrombosis within one week before admission Patients with acute myocardial infarction within one week before admission Patients in whose nose it is difficult to insert esophageal thermal monitoring catheter
Target sample size	100

Research contact person
Name of lead principal investigator	Norikazu Watanabe
Organization	Department of Medicine,Showa university
Division name	Division of Cardiology
Address	Division of Cardiology 1 tyoume 5 no 8 Hatanodai Shinagawaku Tokyo
TEL	03-3784-8000
Email	n-watanabe@med.showa-u.ac.jp

Public contact
Name of contact person	Norikazu Watanabe Kouichirou Inoguchi
Organization	Department of Medicine ,Showa university
Division name	Division of Cardiology
Address	Division of Cardiology 1 tyoume 5 no 8 Hatanodai Shinagawaku Tokyo
TEL	0337848000
Homepage URL
Email	n-watanabe@med.showa-u.ac.jp

Sponsor
Institute	Division of Cardiology , Department of Medicine ,Showa university
Institute
Department

Funding Source
Organization	Division of Cardiology , Department of Medicine ,Showa university
Organization
Division
Category of Funding Organization	Self funding
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	昭和大学病院(東京都)　Showa University Hospital

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 10 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 11 Month 27 Day
Anticipated trial start date	2015 Year 12 Month 10 Day
Last follow-up date	2018 Year 07 Month 01 Day
Date of closure to data entry	2018 Year 07 Month 01 Day
Date trial data considered complete	2018 Year 07 Month 01 Day
Date analysis concluded	2018 Year 07 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	1.There were no significant difference of incidences of ETL , number of more than 39.0 degree ,maximum temperature between ETMC 3 and ETMC 5 . 2.Number of moving ETMC 3 during AFRA was significantly bigger than that of ETMC 5(p=0.0006). 3. Maximum temperature was not was associated with incidence of ETL. 4. Several ETLs were observed below 40 degree in only ETMC3 in the study and our previous study. 5.Weight was associated with incidence of ETL in the study.
Other related information	ETL:esophageal theremal lesion AFRA:atrial fibrilltion cathether ablation ETMC:esophageal thermal monitoring catheters

Management information
Registered date	2015 Year 12 Month 04 Day
Last modified on	2018 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023196