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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046541
Receipt No. R000053104
Scientific Title Observational study of CARTO FINDER of induced atrial fibrillation for paroxysmal atrial fibrillation
Date of disclosure of the study information 2022/01/05
Last modified on 2022/01/05

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Basic information
Public title Observational study of CARTO FINDER of induced atrial fibrillation for paroxysmal atrial fibrillation
Acronym Observational study of CARTO FINDER of induced atrial fibrillation for paroxysmal atrial fibrillation
Scientific Title Observational study of CARTO FINDER of induced atrial fibrillation for paroxysmal atrial fibrillation
Scientific Title:Acronym Observational study of CARTO FINDER of induced atrial fibrillation for paroxysmal atrial fibrillation
Region
Japan

Condition
Condition Paroxysmal atrial fibrillation
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The focal source and rotation in paroxysmal atrial fibrillation are investigated using a cartofinder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes focal source,rotation
Key secondary outcomes Comparison with data of persistent atrial fibrillation

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
85 years-old >
Gender Male and Female
Key inclusion criteria Paroxysmal atrial fibrillation
Atrial fibrillation can be induced and persisted after pulmonary vein isolation
Key exclusion criteria Unable to induce atrial fibrillation after pulmonary vein isolation
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Morio
Middle name
Last name Ono
Organization Showa University Northern Yokohama Hospital
Division name Cardiology
Zip code 224-8503
Address 35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
TEL (+81)45-949-7000
Email morio.ono@gmail.com

Public contact
Name of contact person
1st name Morio
Middle name
Last name Ono
Organization Showa University Northern Yokohama Hospital
Division name Cardiology
Zip code 224-8503
Address 35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
TEL (+81)45-949-7000
Homepage URL
Email morio.ono@gmail.com

Sponsor
Institute University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization nothing
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 Department of Cardiology University Northern Yokohama Hospital
Address 35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
Tel (+81)45-949-7000
Email morio.ono@gmail.com

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 昭和大学横浜市北部病院

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 05 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
2022 Year 01 Month 05 Day
Date of IRB
2022 Year 01 Month 05 Day
Anticipated trial start date
2022 Year 01 Month 05 Day
Last follow-up date
2024 Year 01 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2022 Year 01 Month 05 Day
Last modified on
2022 Year 01 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053104

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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