UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056241 |
|---|---|
| Receipt number | R000063706 |
| Scientific Title | High-power, short duration vs conventional ablation of the superior vena cava isolation for atrial fibrillation |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/11/22 17:38:21 |
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Basic information
Public title
High-power, short duration vs conventional ablation of the superior vena cava isolation for atrial fibrillation
Acronym
High-power, short duration vs conventional ablation of the superior vena cava isolation for atrial fibrillation
Scientific Title
High-power, short duration vs conventional ablation of the superior vena cava isolation for atrial fibrillation
Scientific Title:Acronym
High-power, short duration vs conventional ablation of the superior vena cava isolation for atrial fibrillation
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of high-power, short duration ablation in atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedure time
Number of energization
Key secondary outcomes
Atrial fibrillation recurrence rate at 12 months
Incidence of transverse neuropathy
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient to perform SVC isolation in atrial fibrillation ablation
Key exclusion criteria
Patients with a history of previous superior vena cava isolation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Igawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of Cardiology
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
0459497000
igawa@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Igawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of Cardiology
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
0459497000
Homepage URL
igawa@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Northern Yokohama Hospital
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
Ethics Committee for Research Involving Human Subjects at Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
0337848129
m-rinri@ofc.showa-u.ac.jp
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
| 2024 | Year | 12 | Month | 01 | 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
100
Results
High power short duration superior vena cava ablation was shorter in procedure time and cauterization time.
Results date posted
| 2024 | Year | 11 | Month | 22 | Day |
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
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no related imformation
Management information
Registered date
| 2024 | Year | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063706
