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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032751
Receipt No. 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 2018/05/29

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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
Middle name
Last name Okishige Kaoru
Organization Yokohama City Minato Red Cross Hospital
Division name Cardiology
Zip code
Address 3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa Prefecture 231-8682
TEL 045-628-6100
Email tatsuhiko1984@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuhiko Hirao
Organization Yokohama City Minato Red Cross Hospital
Division name Cardiology
Zip code
Address 3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa Prefecture 231-8682
TEL 045-628-6100
Homepage URL
Email tatsuhiko1984@gmail.com

Sponsor
Institute Yokohama City Minato Red Cross Hospital
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
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
2018 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037304

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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