UMIN-CTR Clinical Trial

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
Email	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
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	Yokohama City Minato Red Cross Hospital
Address	3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa Prefecture 231-8682
Tel	045-628-6100
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037304