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Recruitment status
Unique ID issued by UMIN UMIN000026074
Receipt No. R000029957
Scientific Title Multicenter study on the effectiveness of atrial fibrillation ablation in secondary prevention of cardiogenic cerebral embolism and systemic embolism.
Date of disclosure of the study information 2017/02/10
Last modified on 2017/02/09

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Basic information
Public title Multicenter study on the effectiveness of atrial fibrillation ablation in secondary prevention of cardiogenic cerebral embolism and systemic embolism.
Acronym Study on the effect of atrial fibrillation ablation in secondary prevention of cardiogenic cerebral embolism.
Scientific Title Multicenter study on the effectiveness of atrial fibrillation ablation in secondary prevention of cardiogenic cerebral embolism and systemic embolism.
Scientific Title:Acronym Study on the effect of atrial fibrillation ablation in secondary prevention of cardiogenic cerebral embolism.
Region
Japan

Condition
Condition Atrial fibrillation
Cerebral infarction
Classification by specialty
Cardiology Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to investigate the effectiveness of atrial fibrillation ablation in patients with a history of cardiogenic cerebral embolism and systemic embolism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Recurrence of cardiogenic cerebral embolism and systemic embolism.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with past history of cardiogenic (cerebral, systemic) embolism due to atrial fibrillation and indication for pulmonary venous isolation as a treatment for atrial fibrillation
Key exclusion criteria Patients who have the severe sequela of cerebral embolism to such an extent that it is difficult to safely perform pulmonary artery isolation and patients who are deemed inappropriate by the attending physician due to other complications or clinical course
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Minamino
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Cardiovascular Biology and Medicine
Zip code
Address 1-757 Asahimachidori, Chuouku, Niigata, JAPAN
TEL 025-227-2185
Email mina-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Iijima
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Cardiovascular Biology and Medicine
Zip code
Address 1-757 Asahimachidori, Chuouku, Niigata, JAPAN
TEL 025-227-2185
Homepage URL
Email kenichi@mad.niigata-u.ac.jp

Sponsor
Institute Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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
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 02 Month 10 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
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, we will investigate the effectiveness of pulmonary artery isolation as an effective method for secondary prevention of cardiogenic embolism.

Management information
Registered date
2017 Year 02 Month 09 Day
Last modified on
2017 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029957

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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