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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032506
Receipt No. R000037072
Scientific Title Predictors of Recurrent AF after Cardioversion
Date of disclosure of the study information 2018/05/08
Last modified on 2018/05/08

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Basic information
Public title Predictors of Recurrent AF after Cardioversion
Acronym Predictors of Recurrent AF after Cardioversion
Scientific Title Predictors of Recurrent AF after Cardioversion
Scientific Title:Acronym Predictors of Recurrent AF after Cardioversion
Region
Japan

Condition
Condition Atrial Fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to demonstrate the association between P wave characteristics which might be influenced by atrial electrical inhomogeneity and the incidence of AF recurrence after successful electrical cardioversion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The recurrent AF rate 1 month after electrical cardioversion
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 was previously diagnosed as persistent AF.
Key exclusion criteria The patients were excluded if they had history of open-heart surgery, underwent radiofrequency catheter ablation, and underwent hemodialysis.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuhi Fujimoto
Organization Nippon Medical School
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022 Japan
TEL 03-3822-2131
Email y-fujimoto6081@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuhi Fujimoto
Organization Nippon Medical School
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022 Japan
TEL 03-3822-2131
Homepage URL
Email y-fujimoto6081@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2018 Year 05 Month 08 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 Completed
Date of protocol fixation
2012 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study Type
Prospective Observetional Study

Management information
Registered date
2018 Year 05 Month 08 Day
Last modified on
2018 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037072

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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