UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044673 |
|---|---|
| Receipt number | R000051020 |
| Scientific Title | Superior vena cava Appropriate isolation with Radiofrequency catheter ablation |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2021/06/27 15:30:36 |
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Basic information
Public title
Superior vena cava Appropriate isolation with Radiofrequency catheter ablation
Acronym
SAPPORO-RFCA Study
Scientific Title
Superior vena cava Appropriate isolation with Radiofrequency catheter ablation
Scientific Title:Acronym
SAPPORO-RFCA Study
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to establish the simplified and effective method for SVC isolation and to elucidate the property of the arrhythmogenic SVCs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Establishment of the safe and effective SVC isolation method using the decremental property of arrhythmogenic SVCs
Key secondary outcomes
1. Area, decremental property and conduction velocity of SVCs with or without arrhythmogenesis. 2. Number and locations of breakthrough sites from the RA to SVC. 3. Excitation patterns at the RA-SVC junction during AF induction.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing catheter ablation for atrial fibrillation that requires the use of Pentaray and Lasso catheters for the treatment
Key exclusion criteria
Patients who were judged to be ineligible by a study investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Yokoshiki |
Organization
Sapporo City General Hospital
Division name
Cardiovascular Medicine
Zip code
060-8604
Address
Kita-11, Nishi-13, Chuo-ku, Sapporo 060-8604, Japan
TEL
011-726-2211
hisashi.yokoshiki@doc.city.sapporo.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Toba |
Organization
Sapporo City General Hospital
Division name
Cardiovascular Medicine
Zip code
060-8604
Address
Kita-11, Nishi-13, Chuo-ku, Sapporo 060-8604, Japan
TEL
011-726-2211
Homepage URL
https://www.city.sapporo.jp/hospital/
masahiro-toba@doc.city.sapporo.jp
Sponsor or person
Institute
Sapporo City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo City General Hospital Research Ethics Committee
Address
Kita-11, Nishi-13, Chuo-ku, Sapporo 060-8604, Japan
Tel
011-726-2211
ho.shomu@city.sapporo.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
| 2022 | Year | 07 | 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
Results
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The electrophysiological and anatomical characteristics of arrhythmogenic SVCs
Management information
Registered date
| 2021 | Year | 06 | Month | 27 | Day |
Last modified on
| 2021 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051020
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
