UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029503 |
|---|---|
| Receipt number | R000033707 |
| Scientific Title | Catheter Ablation Using Sensor-Based Electromagnetic Navigation System |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2017/10/10 23:27:12 |
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Basic information
Public title
Catheter Ablation Using Sensor-Based Electromagnetic Navigation System
Acronym
Catheter Ablation Using Sensor-Based Electromagnetic Navigation System
Scientific Title
Catheter Ablation Using Sensor-Based Electromagnetic Navigation System
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yosuke Miwa |
Organization
Kyorin University School of Medicine
Division name
Second Department of Internal Medicine, Department of Cardiology
Zip code
Address
6-20-2 Shinkawa, Mitaka
TEL
+81422475511
y-miwa@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Miwa |
Organization
Kyorin University School of Medicine
Division name
Second Department of Internal Medicine, Department of Cardiology
Zip code
Address
6-20-2 Shinkawa, Mitaka
TEL
+81422475511
Homepage URL
y-miwa@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033707
