UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029013 |
|---|---|
| Receipt number | R000032956 |
| Scientific Title | An observational study to evaluate usefulness of ultra-high resolution mapping for superior vena cava isolation |
| Date of disclosure of the study information | 2017/09/06 |
| Last modified on | 2017/09/05 20:41:37 |
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Basic information
Public title
An observational study to evaluate usefulness of ultra-high resolution mapping for superior vena cava isolation
Acronym
Ultra-high resolution mapping in SVC isolation
Scientific Title
An observational study to evaluate usefulness of ultra-high resolution mapping for superior vena cava isolation
Scientific Title:Acronym
Ultra-high resolution mapping in SVC isolation
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness of of ultra-high resolution mapping for superior vena cava isolation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
technical success of SVC isolation
Key secondary outcomes
electrophysiological findings of SVC assessed by ultra-high resolution mapping
complications during SVC isolation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who undergo catheter ablation of atrial fibrillation
Key exclusion criteria
patients with significant cardiac structure disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuaki Tanaka |
Organization
Yokosuka Kyosai Hospital
Division name
Cardiovascular Center
Zip code
Address
1-16, Yonegahamadori, Yokosuka, Kanagawa
TEL
+81468222710
yasuaki@mxk.mesh.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Tanaka |
Organization
Yokosuka Kyosai Hospital
Division name
Cardiovascular Center
Zip code
Address
1-16, Yonegahamadori, Yokosuka, Kanagawa
TEL
+81468222710
Homepage URL
yasuaki@mxk.mesh.ne.jp
Sponsor or person
Institute
Yokosuka Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 09 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with atrial fibrillation who undergo high-resolution superior vena cava mapping during sinus rhythm after pulmonary vein isolation are enrolled. After the mapping, if initiation of atrial fibrillation from SVC is identified, SVC isolation is performed. We evaluate the outcome, the electrophysiological findings, and complications during SVC isolation.
Management information
Registered date
| 2017 | Year | 09 | Month | 05 | Day |
Last modified on
| 2017 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032956
