UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045244 |
|---|---|
| Receipt number | R000051660 |
| Scientific Title | Utility of cardiac CT virtual transesophageal echocardiography analysis software for preprocedural assessment in left atrial appendgde closure for atrial fibrillation patients |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2024/02/26 15:34:21 |
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Basic information
Public title
Utility of cardiac CT virtual transesophageal echocardiography analysis software for preprocedural assessment in left atrial appendgde closure for atrial fibrillation patients
Acronym
LAAC-CT-TEE
Scientific Title
Utility of cardiac CT virtual transesophageal echocardiography analysis software for preprocedural assessment in left atrial appendgde closure for atrial fibrillation patients
Scientific Title:Acronym
LAAC-CT-TEE
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with atrial fibrillation who underwent appendage closure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Utility of cardiac CT virtual transesophageal echocardiography analysis software
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 underwent left atrial appendage closure, who had cardiac CT more than 64 row, within a year prior to the procedure.
Key exclusion criteria
Patients who denied participation in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Morino |
Organization
Iwate Medical University
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba, Iwate, Japan
TEL
019-613-7111
ymorino@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Nakajima |
Organization
Iwate Medical University
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba, Iwate, Japan
TEL
019-613-7111
Homepage URL
ynaka@iwate-med.ac.jp
Sponsor or person
Institute
Division of Cardiology, Department of Internal Medicine, Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
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
Iwate Medical University
Address
1-1-1 Idaidori, Yahaba, Iwate
Tel
019-651-5111
kenkyu-rinri@j.iwate-med.ac.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
| 2021 | Year | 09 | 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
66
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
Main results already published
Date of protocol fixation
| 2021 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Use CT, echo, and patient background information
Management information
Registered date
| 2021 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051660
