UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040200 |
|---|---|
| Receipt number | R000045335 |
| Scientific Title | Clinical utility of preprocedural cardiovascular magnetic resonance imaging in patients undergoing percutaneous left atrial appendage closure |
| Date of disclosure of the study information | 2020/04/20 |
| Last modified on | 2025/04/23 18:57:30 |
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Basic information
Public title
Clinical utility of preprocedural cardiovascular magnetic resonance imaging in patients undergoing percutaneous left atrial appendage closure
Acronym
LAAC-MRI study
Scientific Title
Clinical utility of preprocedural cardiovascular magnetic resonance imaging in patients undergoing percutaneous left atrial appendage closure
Scientific Title:Acronym
LAAC-MRI study
Region
| Japan |
Condition
Condition
non-valvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The perpose of this study is to compare measurements of left atrial appendage using caldiovascular magnetic resonance imaging and those using transesophageal echocardiography in patients undergoing percutaneous atrial appendage closure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between TEE and MRI for measurements of LAA in patients undergoing LAAC.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with atrial fibrillation who indicated for treatment of LAAC
Key exclusion criteria
The patients who are under the 20 years old or who are found unfit to be respondent to a survey by physician-in-charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Asami |
Organization
Mitsui Memorial Hospital
Division name
Division of Cardiology
Zip code
101-8643
Address
1 KandaIzumi-cyo, Chiyoda-ku, Tokyo
TEL
+81338629111
asami560725@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kai |
| Middle name | |
| Last name | Ninomiya |
Organization
Mitsui Memorial Hospital
Division name
Division of Cardiology
Zip code
101-8643
Address
1 KandaIzumi-cyo, Chiyoda-ku, Tokyo
TEL
+81338629111
Homepage URL
k-ninomiya@mitsuihosp.or.jp
Sponsor or person
Institute
Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Ethics Committee in Mitsui Memorial Hospital
Address
1 KandaIzumi-cyo, Chiyoda-ku, Tokyo
Tel
+81338629236
c-uno@mitsuihosp.or.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
| 2020 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Manuscript under submission
Publication of results
Unpublished
Result
URL related to results and publications
Manuscript under submission
Number of participants that the trial has enrolled
108
Results
Manuscript under submission
Results date posted
| 2025 | Year | 04 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Manuscript under submission
Participant flow
Manuscript under submission
Adverse events
Manuscript under submission
Outcome measures
Manuscript under submission
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 04 | Month | 19 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045335
