UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020076 |
|---|---|
| Receipt number | R000023196 |
| Scientific Title | Comparison of Efficacy and Safety of esophageal monitoring catheters between with 3 thermocouples and with 5 thermocouples in patients with atrial fibrillation ablation. |
| Date of disclosure of the study information | 2015/12/10 |
| Last modified on | 2018/08/23 12:30:09 |
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Basic information
Public title
Comparison of Efficacy and Safety of esophageal monitoring catheters between with 3 thermocouples and with 5 thermocouples in patients with atrial fibrillation ablation.
Acronym
AFabTC 3 vs. 5
Scientific Title
Comparison of Efficacy and Safety of esophageal monitoring catheters between with 3 thermocouples and with 5 thermocouples in patients with atrial fibrillation ablation.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Norikazu Watanabe |
Organization
Department of Medicine,Showa university
Division name
Division of Cardiology
Zip code
Address
Division of Cardiology 1 tyoume 5 no 8 Hatanodai Shinagawaku Tokyo
TEL
03-3784-8000
n-watanabe@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norikazu Watanabe Kouichirou Inoguchi |
Organization
Department of Medicine ,Showa university
Division name
Division of Cardiology
Zip code
Address
Division of Cardiology 1 tyoume 5 no 8 Hatanodai Shinagawaku Tokyo
TEL
0337848000
Homepage URL
n-watanabe@med.showa-u.ac.jp
Sponsor or person
Institute
Division of Cardiology , Department of Medicine ,Showa university
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
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.
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
Preinitiation
Date of protocol fixation
| 2014 | Year | 11 | Month | 27 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023196
