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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042325
Receipt No. R000048315
Scientific Title The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/02

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Basic information
Public title The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Acronym The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Scientific Title The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Scientific Title:Acronym The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Region
Japan

Condition
Condition atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of voltage guide PVI in atrial fibrillation ablation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The recurrence rate of atrial fibrillation in one year.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 To perform voltage guide PVI
Interventions/Control_2 To perform non-voltage guide PVI
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 To perform 1st session of PVI
Key exclusion criteria To have previous AF ablation
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Kishihara
Organization Kitasato university school of medicine
Division name Department of cardiovascular medicine
Zip code 2520374
Address Kitasato1-15-1, Minami-ku, Sagamihara, JAPAN
TEL 042-778-8111
Email j_kishihara@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name Kishihara
Organization Kitasato university school of medicine
Division name Department of cardiovascular medicine
Zip code 2520374
Address Kitasato1-15-1, Minami-ku, Sagamihara, JAPAN
TEL 042-778-8111
Homepage URL
Email j_kishihara@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato university
Institute
Department

Funding Source
Organization None
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 The institutional ethics committee of hospital of the Kitasato University School of Medicine.
Address Kitasato1-15-1, Minami-ku, Sagamihara, JAPAN
Tel 042-7778-8111
Email rinrib@med.kitasato-u.ac.jp

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
2020 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 02 Day
Last modified on
2020 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048315

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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