UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049923 |
|---|---|
| Receipt number | R000056863 |
| Scientific Title | Blood flow analysis in the left atrium after left atrial plication with 4D flow MRI and CFD |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2022/12/27 20:17:04 |
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Basic information
Public title
Blood flow analysis in the left atrium after left atrial plication with MRI and CT
Acronym
Blood flow analysis in the left atrium after left atrial plication with MRI and CT
Scientific Title
Blood flow analysis in the left atrium after left atrial plication with 4D flow MRI and CFD
Scientific Title:Acronym
Blood flow analysis in the left atrium after left atrial plication with 4D flow MRI and CFD
Region
| Japan |
Condition
Condition
persistent atrial fibrillation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is reported left atrial (LA) enlargement is the predictor of the prognosis and adverse events such as MACE. Left atrial plication (LAP) for giant LA is considered to improve the respiratory function and therapeutic effect of the Maze procedure, and to be useful for mitral valve plasty for atrial mitral regurgitation recently. We suppose that LAP for giant LA will improve the stagnation of the blood flow in the LA, but there are no reports of evaluation of the blood flow in the LA after LAP. The purpose of this study is to demonstrate that LAP could improve the stagnation in the LA with 4D flow MRI and CFD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of the stagnation in LA with LAP.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We studied 10 patients who were performed mitral valve plasty or replacement and LAP after July 1, 2021. All patients had chronic atrial fibrillation over 10 years with LA diameter over 60mm. The procedure of the LAP is plication of left atrial wall from the anterior edge of the left atrial appendage to the caudal edge of the right side left atriotomy with continuous sutures.
We perform contrast-enhanced CT and 4D flow MRI before and after the operation, analyze the blood flow in the LA based on the image, and visually evaluate the stagnation in the LA. The imaging data is analyzed at Cardio Flow Design Co., Ltd.
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
All patients had chronic atrial fibrillation over 10 years with LA diameter over 60mm, and done mitral valve surgery after July 1, 2021, at Niigata university medical and dental hospital.
Key exclusion criteria
emergency surgery, bacterial endocarditis, surgery with circulatory arrest, cases using IABP or catecholamine preoperatively
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takehito |
| Middle name | |
| Last name | Mishima |
Organization
Niigata university graduate school of medical and dental sciences
Division name
Division of thoracic and cardiovascular surgery
Zip code
9518510
Address
1-757 Asahimachidori, Chou-ku, Niigata-shi, Niigata, 951-8510, Japan
TEL
025-227-2243
bu3n9d@bma.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Enomoto |
Organization
Niigata university graduate school of medical and dental sciences
Division name
Division of thoracic and cardiovascular surgery
Zip code
9518510
Address
1-757 Asahimachidori, Chou-ku, Niigata-shi, Niigata, 951-8510, Japan
TEL
025-227-2243
Homepage URL
bu3n9d@bma.biglobe.ne.jp
Sponsor or person
Institute
Division of thoracic and cardiovascular surgery, Division of thoracic and cardiovascular surgery
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
Ethics Committee of Niigata University
Address
1-757 Asahimachidori, Chou-ku, Niigata-shi, Niigata, 951-8510, Japan
Tel
025-227-2005
joho@med.niigata-u.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
| 2022 | Year | 12 | Month | 28 | 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
| 2021 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 30 | 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
Management information
Registered date
| 2022 | Year | 12 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056863
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