UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017353 |
|---|---|
| Receipt number | R000020132 |
| Scientific Title | Histological assessment of transmurality after repeated radiofrequency ablation of the left atrial wall. |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2015/04/30 19:12:34 |
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Basic information
Public title
Histological assessment of transmurality after repeated radiofrequency ablation of the left atrial wall.
Acronym
Histological assessment of transmurality after repeated radiofrequency ablation of the left atrial wall.
Scientific Title
Histological assessment of transmurality after repeated radiofrequency ablation of the left atrial wall.
Scientific Title:Acronym
Histological assessment of transmurality after repeated radiofrequency ablation of the left atrial wall.
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of bipolar radio-frequency device in terms of the histological transmurality of the ablation lesion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transmurality
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent Maze procedure for atrial fibrillation in Hokkaido University Hospital
Key exclusion criteria
Patients who were considered to be unsuitable for the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiro Matsui |
Organization
Graduate School of Medicine, Hokkaido University
Division name
Cardiovascular and Thoracic Surgery
Zip code
Address
W7N15, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-6042
ymatsui@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Wakasa |
Organization
Graduate School of Medicine, Hokkaido University
Division name
Cardiovascular and Thoracic Surgery
Zip code
Address
W7N15, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-6042
Homepage URL
wakasa@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University 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
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
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | 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
Published
Management information
Registered date
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2015 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020132
