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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028470
Receipt No. 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

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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
Email 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
Email morio.ono@gmail.com

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032590

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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