UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028470 |
|---|---|
| Receipt number | R000032590 |
| Scientific Title | Investigation of left atrial function by MRI for patients who underwent catheter ablation for atrial fibrillation |
| Date of disclosure of the study information | 2017/08/04 |
| Last modified on | 2017/07/31 23:35:53 |
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Basic information
Public title
Investigation of left atrial function by MRI for patients who underwent catheter ablation for atrial fibrillation
Acronym
Investigation of left atrial function by MRI for patients who underwent catheter ablation for atrial fibrillation
Scientific Title
Investigation of left atrial function by MRI for patients who underwent catheter ablation for atrial fibrillation
Scientific Title:Acronym
Investigation of left atrial function by MRI for patients who underwent catheter ablation for atrial fibrillation
Region
| Japan |
Condition
Condition
Paroxysmal atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
If it is paroxysmal atrial fibrillation, it is confined to the heart muscle of the pulmonary vein and its surroundings, and it is the basis of treatment to electrically isolate these tissues from the left atrium. Left atrial circumferential and BOX isolation using anatomical indicators and electrophysiological indicators are recommended in the Guidelines of the Japanese Circulation Society. However, it is unknown comparison of atrial function for patients who underwent left atrial circumferential or BOX isolation for atrial fibrillation. Therefore, I would like to clarify these by using MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Comparison of left atrial function before and 3 months and 6months after treatment
Key secondary outcomes
Comparison of maintaining sinus rhythm and BNP before and 3 months and 6months after treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Catheter ablation
Circumferential isolation or BOX isolation
Interventions/Control_2
Catheter ablation
BOX isolation
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients meeting the paroxysmal atrial fibrillation diagnostic criteria of the Japanese Cardiovascular Society guideline
2) Patients who aged 20 to over 80 years of age at the time of acquisition.
3) Patient who is not enforced catheter ablation for atrial fibrillation by the time of obtaining consent.
4) Patient who consented to the participation in this exam by written document.
Key exclusion criteria
1) Patients contraindicated for MRI examination.
2) Patients complicated with congenital heart disease.
3) Person who judged ineligible due to judgment of examining physician.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morio Ono |
Organization
Showa University Northern Yokohama Hospital
Division name
Cardiovasular catheter Lab
Zip code
Address
35-1 Chigasaki Tuduki Yokohamacity Kanagawa
TEL
045-949-7000
morio.ono@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Morio Ono |
Organization
Showa University Northern Yokohama Hospital
Division name
Cardiovasular catheter Lab
Zip code
Address
35-1 Chigasaki Tuduki Yokohamacity Kanagawa
TEL
045-949-7000
Homepage URL
morio.ono@gmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Northern Yokohama 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
| 2017 | Year | 08 | Month | 04 | 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 | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 31 | Day |
Last modified on
| 2017 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032590
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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