UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045694 |
|---|---|
| Receipt number | R000051603 |
| Scientific Title | The comparison of voltage guide and non-voltage guide SVC isolation in patients with atrial fibrillation. |
| Date of disclosure of the study information | 2021/10/10 |
| Last modified on | 2024/04/09 14:04:50 |
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Basic information
Public title
The comparison of voltage guide and non-voltage guide SVC isolation in patients with atrial fibrillation.
Acronym
The comparison of voltage guide and non-voltage guide SVC isolation in patients with atrial fibrillation.
Scientific Title
The comparison of voltage guide and non-voltage guide SVC isolation in patients with atrial fibrillation.
Scientific Title:Acronym
The comparison of voltage guide and non-voltage guide SVC isolation in patients with 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 efficacy of voltage guide SVC isolation in atrial fibrillation ablation.
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
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
To perform SVC isolation on af ablation
Key exclusion criteria
To have previous SVC isolation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Jumpei |
| Middle name | |
| Last name | Saito |
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
saijun0960@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Saito |
| Middle name | |
| Last name | Jumpei |
Organization
Showa University Yokohama Northern Hospital
Division name
Cardiovascular Medicine
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
0459497000
Homepage URL
saijun0960@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Yokohama Northern Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Yokohama Northern 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
| 2021 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051603
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051603
Number of participants that the trial has enrolled
90
Results
Voltage-guided superior vena cava isolation resulted in fewer ablation points.
Results date posted
| 2024 | Year | 04 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients undergoing atrial fibrillation ablation for the first time
Participant flow
Outpatient follow-up results not required.
Adverse events
There are no adverse events.
Outcome measures
Number of ablation points,clinical complications
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 31 | Day |
Other
Other related information
no related imformation
Management information
Registered date
| 2021 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051603
