UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Catheter Ablation Using Sensor-Based Electromagnetic Navigation System
Title of the study (Brief title)	Catheter Ablation Using Sensor-Based Electromagnetic Navigation System
Region	Japan

Condition
Condition	Tachyarrythmia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Quantification of Radiation Exposure Reduction in Catheter Ablation Using 3D Navigation System
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Radiation dose, Fluoroscopic time, Radiation exposure on Dosimeter
Key secondary outcomes	Outcome (3, 6, 12 month), Complications

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	Catheter Ablation with Electroanatomical Mapping System and 3D Navigation system
Interventions/Control_2	Catheter Ablation with Conventional 3D-Electroanatomical Mapping System
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	Catheter Ablation for Tachyarrhythmia (including Atrial Fibrillation, Atrial Flutter, Supraventricular Tachycardia, Ventricular Tachycardia)
Key exclusion criteria	Not Obtain Informed Consent Not Follow up for 1 year
Target sample size	100

Research contact person
Name of lead principal investigator	Yosuke Miwa
Organization	Kyorin University School of Medicine
Division name	Second Department of Internal Medicine, Department of Cardiology
Address	6-20-2 Shinkawa, Mitaka
TEL	+81422475511
Email	y-miwa@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Yosuke Miwa
Organization	Kyorin University School of Medicine
Division name	Second Department of Internal Medicine, Department of Cardiology
Address	6-20-2 Shinkawa, Mitaka
TEL	+81422475511
Homepage URL
Email	y-miwa@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University School of Medicine
Institute
Department

Funding Source
Organization	Kyorin University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 10 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 10 Day
Last modified on	2017 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033707