UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032751 |
|---|---|
| Receipt number | R000037304 |
| Scientific Title | Prospective unblinded randomized controlled trial of the effectiveness and safety of 30 W output and 50 W output in the cavotricuspid isthmus linear ablation for common atrial flutter |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2021/10/08 07:04:00 |
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Basic information
Public title
Prospective unblinded randomized controlled trial of the effectiveness and safety of 30 W output and 50 W output in the cavotricuspid isthmus linear ablation for common atrial flutter
Acronym
compcarison of 30W output and 50W output inthe cavotricuspid isthmus linear ablation for common atrial flutter
Scientific Title
Prospective unblinded randomized controlled trial of the effectiveness and safety of 30 W output and 50 W output in the cavotricuspid isthmus linear ablation for common atrial flutter
Scientific Title:Acronym
compcarison of 30W output and 50W output inthe cavotricuspid isthmus linear ablation for common atrial flutter
Region
| Japan |
Condition
Condition
common atrial flutter
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the treatment of catheter ablation of cavotricuspid isthmus, we compare 30 W and 50 W output for the time to make the lesion, total procedure time, safety and effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total ablation time to make complete cavotricuspid isthmus blockline, total procedure time, incidence of complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventions: ablation at 50 W 10 - 12 seconds
Interventions/Control_2
Control: ablation at 30 W 30 seconds
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
Catheter ablation case for atrial fibrillation, atrial flutter
Key exclusion criteria
Recurrence case after ablation of tricuspid vena cavitalis previously performed
History of congenital heart disease, heart surgery and cardiac tamponade
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Okishige |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Cardiology
Zip code
231-8682
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa Prefecture 231-8682
TEL
045-628-6100
tatsuhiko1984@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Hirao |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Cardiology
Zip code
231-8682
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa Prefecture 231-8682
TEL
045-628-6100
Homepage URL
tatsuhiko1984@gmail.com
Sponsor or person
Institute
Yokohama City Minato Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City Minato Red Cross 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
Yokohama City Minato Red Cross Hospital
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa Prefecture 231-8682
Tel
045-628-6100
s-furuta.ji@yokohama.jrc.or.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
| 2018 | Year | 10 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 29 | Day |
Last modified on
| 2021 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037304
| 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 |
